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For July 20, 2017. Artificial Intelligence is about to play a major role in the pharmaceutical industry. On July 2nd of this year, Glaxo-Smith-Kline revealed a 43-million dollar deal in which they will use A.I. to make the process of discovering new drugs easier. The goal is to reduce the time it takes from identifying a target for disease intervention to finding a molecule that acts against it. He hopes to bring it from an average 5 and a half years today to just one year in the very near future.

Category:general -- posted at: 11:29am MST

Occupational Toxicology and Occupational Medicine - Where are they the same and where are they different? In this episode of the BioPharma EHS Podcast, Dean M. Calhoun, President and CEO of Affygility Solutions hosts a discussion between Dr. Mark Cunningham-Hill, President of Worldwide Health Consulting LLC and Dr. Frank Richardson, Principal Toxicologist for Affygility Solutions LLC.

The discussion starts out covering the basic elements of an occupational medicine program and the unique challenges posed by the pharmaceutical industry in which occupational exposure to potent compounds can cause adverse effects in workers. Then the discussion switch over to discussing occupational toxicology, dermal exposures to such compounds as fentanyl or nicotine, and hypersensitivity.

The discussion ends and Dean Calhoun then discusses upcoming events and happenings of importance to environmental, health and safety professionals in the life sciences industry.

Direct download: Biopharma_EHS_podcast_episode_25.mp3
Category:general -- posted at: 2:15pm MST

In Episode #24 of the Biopharma EHS podcast, Dean M. Calhoun, CIH discusses with Dr. Joe Nieusma, Senior Occupational Toxicologist for Affygility Solutions, the "Mystery of Cytotoxic Compounds." For multi-product pharmaceutical manufacturing facilities, this often a controversial topic since many people believe that cytotoxic compounds require dedicated facilities or equipment. It is also a topic of debate when setting occupational exposure limits and acceptable daily exposure values for active pharmaceutical ingredients.

Direct download: biopharma-ehs-podcast-episode-24.mp3
Category:general -- posted at: 5:27pm MST

In this episode of the Biopharma EHS podcast, Dean M. Calhoun, CIH, President and CEO of Affygility Solutions interviews Kevin Rosenthal of Pharmatek Laboratories. During the interview we discuss handling potent compounds, potent compound safety, and occupational control banding.

Dean Calhoun also responds to the frequently asked question, "What type of equipment do I need to handle a highly potent compound?"

 

If you would like to learn more, visit affygility.com

Direct download: Biopharma_EHS_podcast_episode_23_final.mp3
Category:general -- posted at: 8:36pm MST

In this episode of the Biopharma EHS Podcast, Dean M. Calhoun, CIH, President and CEO of Affygility Solutions, interviews Ms. Stephanie Wilkins, President of PharmaConsult US, on the subject of Risk-MaPP, ADEs and PDEs: Their importance to multi-product pharmaceutical manufacturing facilities. Risk-MaPP stands for Risk-Based Manufacture of Pharmaceutical Products. It is one of the International Society of Pharmaceutical Engineers' (ISPE) Base-line Guides. One of the essential components of Risk-MaPP is the determination of acceptable daily exposure (ADE) values. Calculation of ADEs is similar to the calculation of PDEs presented by European Medicines Agency (EMA). If you need an occupational exposure limit (OEL) or ADE for a pharmaceutical compound, please check out our entire catalog of OEL Fastrac monographs. We have many OEL monographs that come with ADEs.

Direct download: Biopharma_EHS_podcast_Episode_22.mp3
Category:general -- posted at: 10:58am MST

BioPharma EH&S Podcast Episode No. 20

Hello everybody and welcome back to another Episode of the BioPharma EH&S Podcast, my name is Dean Calhoun of Affygility Solutions and this is the podcast dedicated to discussing critical environmental, health and safety issues facing the biopharma industry, helping you take your environmental, health and safety programs to the next level.

 Well, it’s Sunday, July 14th, 2013 and it’s great to be here today. We have great show in store for you today and a lot of things to talk about, so let’s go ahead and get started.

 As always, I’d like to first mention what we are going to discuss in today’s podcast.  That way you can decide if it’s something that interests you, or should you just come back for our next episode.  In today’s podcast, we’re going to talk about the following topics. 

First, I’ll briefly cover what we talked about last time in episode number 19 

Then I will cover our main topic for today, which is EH&S Software – The Challenge of User Adoption

And finally, we’ll discuss upcoming events and happenings of importance to environmental, health and safety professionals in the BioPharma Industry.

So, let’s go ahead get started.  Last time in Episode number 19 we discussed the topic of “The Future of Potent Compound Safety – the next 100 years.”  In that Podcast, I presented four emerging trends that will shape the future of the pharmaceutical industry. Those trends included first, the development of medicines in space; second, the trend called “the Internet of Things;” third, the Maker Movement; and forth and finally, the Use of Big Data Tools.  If that’s something that may interest you, I would suggest that you go back and listen to Episode 19.

Alright, let’s now move on to our main topic for today which is EHS software – the challenge of user adoption. So without further delay, here we go.

 A little over a year ago, I created a post on EHS Compliance Management Software - Increasuing User Adoption and Engagement. In that post, I provide a few suggestions for encouraging user adoption of EHS software within an organization. The suggestions i provided by then included:

- Measure usage;

- Ensure data quality;

- Engage users during meetings;

- Tie individual compensation to usage; and

- Use peer pressure.

In addition to those five suggestions listed above, I would like to provide some additional suggestions. These additional suggestions include:

- Ensure executive leadership involvement;

- Identify and reward super users;

- Perform floor-walking;

- Ensure that the EHS software system is used by taking the approach, "If it isn't in the EHS software system, it didn't happen;"

- Mandate both timeliness and data quality.

O.k., that does it for our main topic, let’s now talk about some upcoming events.

Alright that does it for our main topic this week. One additional item that I would like to remind everyone of is oelfastrac.com, which is a convenient and affordable way to obtain high-quality occupational exposure limit monographs for common APIs. To learn more, please go to oelfastrac.com.

 O.k.  That does it for this week’s show.  Remember to submit your questions to our podcast email at info@affygility.com.  You can also follow us on twitter at twitter.com/Affygility, on Facebook at facebook.com/affygilitysolutions and giving us a “Like”, and finally on LinkedIn by searching for Affygility Solutions.

That does it for this week’s show.  We look forward to having you listen in next time.

Have a great rest of the day.

Direct download: BP_EHS_20_Final.mp3
Category:general -- posted at: 2:49pm MST

In this podcast, Dean M. Calhoun of Affygility Solutions discusses four key technologies or trends that will have a significant impact on the pharmaceutical industry for the next 100 years. These trends include: the development of medicines in space, the Internet of Things, the Maker movement, and the use of Big Data tools. He will also discuss taking leaps forward and barriers that we will encounter.

Direct download: biopharma-ehs-podcast-20.mp3
Category:general -- posted at: 10:53pm MST

In this presentation, Dean M. Calhoun, CIH, with certification in industrial hygiene by the American Board of Industrial Hygiene (ABIH) discusses the key concepts and principles that need to be considered when auditing biotechnology and pharmaceutical facilities for potent compound safety issues. His talk was presented at the World Highly Potent Active Pharmaceutical Ingredient Summit in Philadelphia, PA in June of 2012. If you have any questions regarding potent compound safety, EHS auditing, occupational toxicology or industrial hygiene, please contact Affygility Solutions.

Direct download: EHS_Auditing_of_High_Potency_Facilities.mov
Category:general -- posted at: 8:28pm MST

Nanotechnology and the Pharmaceutical Industry - an interview with Don Ewert of OSO Biopharmaceuticals.

Hello everybody and welcome back to another episode of the BioPharma EH&S Podcast, my name is Dean Calhoun of Affygility Solutions and this is the podcast dedicated to discussing critical environmental, health and safety issues facing the biopharma industry, helping you take your environmental, health and safety programs to the next level.

Overview

I’ll briefly cover what we talked about last time in episode number 17

 Then I will cover our main topic for today, which is an interview with Don Ewert, Environmental, Health and Safety Manager for OSO Biopharmaceuticals.  In this interview Don and I will discuss nanotechnology and some of the key environmental, health and safety issues surrounding this emerging technology

And finally, we’ll discuss upcoming events and happenings of importance to environmental, health and safety professionals in the BioPharma Industry.

So, without further delay, let’s go ahead get started.  Last time in Episode number 17 we discussed the topic of “Containment Validation and Surrogate Monitoring.”  In that Podcast, Matt Meiners, Laboratory Services Manager for Bureau Veritas and I discussed what is surrogate monitoring, some of the key factors to consider when selecting a surrogate compound, and finally, what are some of the common mistakes that occur when performing containment validation and surrogate monitoring.  It was a great interview, and I appreciate Matt taking the time out of his busy schedule to participate. If that’s something that may interest you, I would suggest that you go back and listen to Episode 17.

 

Alright, let’s now move on to our main topic for today which is an interview with Don Ewert, Environmental, Health and Safety Manager on nanotechnology.  I should mention ahead of time, that this section of the podcast was recorded on January 19th, 2012 via Skype.  There is a few instances where we have a Skype garble moment, so I do apologize in advance for that. So without further delay, here we go.

[audio portion]

 O.k., that does it for our main topic, let’s now talk about some upcoming events.

 The first set of events that I would like to mention is in early February.  In February, Affygility Solutions has several webinars starting and I would suggest that look at our schedule at Affygility.com.  These webinars have been extremely popular and we have received a lot of positive feedback on them.  In February, we have a new webinar on Manufacturing Highly Potent Compounds – Understanding and Controlling the Risks.  This is a brand new webinar and we are very excited to be premiering it.  It you are an certified industrial hygienist and involved in potent compound safety, certification points are available.  Additional webinars for the month of February include our every popular isoflurane safety webinar.  Again, if any of that interests you, I would suggest that you go to Affygility.com and look at our full schedule.

The next event that I would like to mention is the annual Society of Toxicology conference to be held on March 11th through 15th in San Francisco.  Affygility Solutions won’t be exhibiting at this conference, but our Senior Toxicologist, Joe Nieusma, may be attending.  If you would like more information on this conference go to the Society of Toxicology’s website at sot.org

 Then at the end of March, the Society of Chemical Hazard Communication will be having it’s Spring Meeting in Nashville, TN.  We haven’t decided if we will attend this meeting or not, but in any case, these are usually very informative event and with GHS due to be finalize in early 2012 I’m sure there will be great sessions. You should go to their website for more information.  The URL for their website will be in the show notes.

 O.k.  That does it for this week’s show.  Remember to submit your questions to our podcast email at podcast at Affygility.com.  You can also follow us on twitter at twitter.com/Affygility, on Facebook at facebook.com/affygilitysolutions and giving us a “Like”, and finally on LinkedIn by searching for Affygility Solutions.

That does it for this week’s show.  We look forward to having you listen in next time.

About Affygility Solutions. Affygility Solutions provides environmental, health and safety software and services to the pharmaceutical, biotechnology, and medical device industry. 

 Have a great rest of the day.

Direct download: BioPharma_EHS_Podcast_Episode_18.mp3
Category:general -- posted at: 8:23am MST

Containment Validation and Surrogate Monitoring

In this episode of the Biopharma EHS podcast, Dean M. Calhoun, CIH, President and CEO of Affygility Solutions discusses the following topics:

  • A review of Episode no. 16 of the Biopharma EHS podcast.  In that episode, Dean M. Calhoun, President and CEO of Affygility Solutions, and Dr. Joe Nieusma, Sr. Occupational Toxicologist with Affygility Solutions discuss Category 4 and 5 potent compounds.  Our discussions include what factors determine a Category 4 or 5 potent compound, why the occupational exposure limit (OEL) alone is not enough to determine if a specific compound falls into a category 4 or 5 control band, and specific examples of potent compounds that are classified into these control bands.
  • An interview with Matt Meiners, Division Manager, Laboratory Services for the Bureau Veritas, Lake Zurich, Industrial Hygiene Laboratory.  In this interview, Dean and Matt discuss containment validation and surrogate monitoring.  Matt provides insight into why containment validation is necessary, the advantages and disadvantages of different surrogate compounds, the sensitivity of their industrial hygiene laboratory methods for surrogate compounds, the advantages and disadvantages of the total dust versus the Institute of Occupational Medicine (IOM) method of sampling.
  • Upcoming events and happenings of interest to environmental, health and safety professionals in the biotechnology, pharmaceutical, and medical device industries.  These events include:
  • The above webinars are a great way for environmental, health and safety professionals to obtain certification maintenance points.

If you have questions regarding this podcast, please email podcast @ affygility.com

 

Direct download: Biopharma_EHS_podcast_Episode_17.mp3
Category:general -- posted at: 8:04am MST

In this podcast, Dean M. Calhoun, CIH and Joe Nieusma, Ph.D. of Affygility Solutions discuss Category 4 and Category 5 Potent Compounds - Understanding the Risks.

Items covered include:

  • Review of the last podcast
  • What factors go into determining an active pharmaceutical ingredients as a Category 4 or Category 5 potent compound
  • We provide examples of Category 4 and Category 5 potent compounds
  • Review upcoming events and happenings related to environmental, health and safety in the biotechnology, pharmaceutical, and medical device industry.

If you have any questions please contact Affygility Solutions at 303-884-3028 or visit the Affygility Solutions website.

Direct download: Biopharma_EHS_Podcast_Episode_No._16.mp3
Category:general -- posted at: 11:51am MST

BioPharma EHS Podcast Episode No. 15 - Thursday, April 21, 2011. We have a lot of great things to talk about.  But before I tell you what were going to discuss I should mention that the twitter hashtag for today’s podcast is #biopharma15.  For those of you that don’t know how to use Twitter and believe it’s useless, you should really try it out.  OSHA, the EPA, NIOSH and many other agencies and organizations are using twitter. I will put a link to how to use hashtags in the shownotes:

 

http://mashable.com/2009/05/17/twitter-hashtags/

 

O.k., so what are we going to discuss in today’s podcast. In today’s podcast, we’re going to talk about the following topics. 

 

First, I’ll briefly cover what we talked about last time in episode number 14

 

Then, we will answer some of listener questions that where sent in, which will lead us into our main topic for today, which is Control Banding – how many bands is enough?

 

And finally, I’ll then discuss upcoming events and happenings of importance to environmental, health and safety professionals in the BioPharma Industry.

 

So, let’s go ahead get started.  Last time in Episode 14 we discussed the topic of “Young Guns of Environmental, Health and Safety.”  Which was mainly about the younger generation of environmental, health and safety professionals that are entering the workforce. It that episode we discussed some of their priorities, communication styles, and technology interests.  The audio and video portion of this presentation is available online and I will put a link to the presentation in the shownotes.

 

Questions on peptides and protein therapeutics.

 

Questions on skin absorption and molecular skin, and the maximum amount of skin absorption.

 

We have another question regarding control banding.

 

In some cases, we have MSDS’s that list an acceptable occupational exposure limit (or similar terminology).  Is it reasonable for us to translate those numbers directly into the control band categories?  For example, if I have an MSDS that lists a TWA exposure limit of 5 ug/m3.  On a four band system I have that category 3 means OELs ranging from 30 ng/m3 to 10 ug/m3.  So is that a reasonable justification for us to communicate that the compound is Category 3 (per the information in this MSDS)?  Without repeating the risk assessment of all the factors that go into it (and having someone sufficiently trained on how to put them together.)

 

Thank you Corinne for the question.  A couple of comments here.  The first comment is that you should remember that placement of a compound into a control band category should be based on a whole picture approach, not just the OEL. The OEL is only one factor that you need to consider, potential for skin absorption, irritation, sensitization and other effects need to be consider.  Placement of a compound into a hazard category and determination of the OEL is based on the toxicology of the compound.

 

The second comment is the number of control bands that you have really depends upon the number of control options available to your company.  The number of control bands should be company specific, and that the width of each of the bands should be based on a solid understanding of containment validation.  I’ve seen companies that were using powders weighing hoods, but because of poor work practices were not getting anywhere near the level of containment they should be achieving.

 

The final point is risk equals hazard times probability.  As we just mentioned, the hazard of the compound depends upon its toxicology, the probability of exposure depends on many factors such as physical form, such as a dry powder, wet cake, or liquid, and the quantity handled, the frequency handled, the duration handled and many other factors.  So you need to consider both the hazard of the compound and the probability of exposure when assigning a risk.  For example, you can have a hazard category 4 or 5 compound in a sealed double container and the probability of exposure is almost zero, so the risk of handling the sealed drum is almost zero.

 

O.k. are next comment is from Nicole.

 

Hello Dean -

 

I was at a company that used a 5 band system.  At my current company, it

is a four band system .  Since most of our

compounds are in early stage development, every compound is in the same

default band.

 

The presentation was very good.  Obviously, both of you have a lot of

experience.  It was very good to hear the case studies.

 

Thank you,


 

First off, thank you Nicky so much for the kind comments Joe and I really appreciate them.

 

That does it for our questions, if any of you have any other questions please email them to me at podcast at Affygility.com

 

Alright, that does it for our main topic, let’s now talk about some upcoming events.

 

The first event that I would like to mention is the annual American Industrial Hygiene Conference and Exposition is coming up on May 14-19th in Portland, OR.  I won’t be attending the conference this year since my daughter is graduating from high school during that time.

 

Then in June, on the 12th through 15th, we have the American Society of Safety Engineers Annual Conference in Chicago, IL.

 

O.k.  That does it for this week’s show.  Remember to submit your questions by emailing podcast@affygility.com and stalk us on twitter at twitter.com/Affygility, on Facebook by searching for Affygility Solutions and giving us a “Like”, and finally on LinkedIn by searching for Affygility Solutions.

 

That does it for this week’s show.  We look forward to having you listen in next time.

 

 

 

 

 

 

 

 

 

 

Direct download: BioPharma_EHS_Podcast_Episode_15.mp3
Category:general -- posted at: 3:28pm MST

Our main topic for today is the Young Guns of Environmental, Health and Safety

 

 

[listen to podcast for details]

 

Alright, that does it for our main topic, let’s now talk about some upcoming events.

 

First I should mention, that coming up next week, we have several new webinars starting and you should look at our schedule at Affygility.com.  These webinars have been very well attended and we have received a lot of positive feedback on them.  In addition to our very popular webinar on Advanced Topics in Potent Compound Safety, we also have a webinar on Dermal Exposure to Active Pharmaceutical Ingredients, Global Harmonization System, Hazardous Wastes for Hospitals, Clinics, and Medical Laboratories.  Again, if any of that interests you, I would suggest that you go to Affygility.com and look at our full schedule.

 

O.k.  That does it for this week’s show.  Remember to submit your questions to our voicemail feedback line at 206-337-4769 and stalk us on twitter at twitter.com/Affygility, on Facebook by searching for Affygility Solutions and giving us a “Like”, and finally on LinkedIn by searching for Affygility Solutions.

 

That does it for this week’s show.  We look forward to having you listen in next time.

 

Have a great rest of the day.

Direct download: BioPharma_EHS_Podcast_14.mp3
Category:general -- posted at: 6:55pm MST

In this podcast, Dean Calhoun of Affygility Solutions discusses Social Media and Environmental, Health and Safety

The twitter hashtag for today’s podcast is #socialehs

 

 First, I’ll briefly cover what we talked about last time in episode number 12

 

 Then I will cover our main topic for today, which is the use of Social Media in Environmental, Health and Safety industry.

 

 And finally, I’ll then discuss upcoming events and happenings of importance to environmental, health and safety professionals in the BioPharma Industry.

Last time in Episode 12 we discussed the topic of “Creeping Featurism of Environmental, Health and Safety software."  In that episode I shared my four observations regarding the evolution of environmental, health and safety software.  Those four observations were, first, everybody seems to want a comprehensive system that is off the shelf.  Complete with every bell and whistle, and one that keeps track of every possible requirement, emission, or metric.  The problem I have with this is, “in most companies with limited environmental, health and safety staff who is going to enter all this data?” My 2th observation was that an environmental, health and safety management system is not equal to MIS, my 3rd observation was that configuration does not equal customization, and my 4th and final observation is that comprehensive systems are pricey.  In episode 12 I also shared some questions that you might want to ask yourself prior to selecting a system.  So, if any of that interests you I suggest you go back and listen to episode 12 and listen to the whole thing.

Alright, now before we move into our next topic, I might indicate that it’s going to be slightly different than previous topics that I’ve discussed. For those of you that have been listening in to previous episodes, most of you know that I recently attended South by Southwest Interactive in Austin, Texas.  First off South by Southwest was an amazing conference and the speakers were great, and the attendees were awesome – all 19,000 plus of them.  Many of the sessions that I attended dealt with social media and that inspired me to talk about today’s main topic, which is the use of Social Media in Environmental, Health and Safety.

·      So what exactly is Social Media?

·      So why Social Media?

·      Who is using Social Media? OSHA, NIOSH, U.S. Environmental Protection Agency all have Facebook pages and twitter feeds. The National Association for Environmental Management (NAEM), American Industrial Hygiene Association (AIHA), American Biological Safety Association (ABSA) and many other professional organizations.

·      What’s the value in Social Media?

     Who is doing it right?

What are the challenges of social media. 

 

·      As a final comment regarding social media, allow the users to have an opinion and to be human. Social media can get a little messy at times with mis-spelled words, the use of slang or jargon, and the occasional use of profanity.  As stated before, it will have to be moderated, but again, be careful not to over moderate.

O.k.  The does it for the discussion on “Social Media in Environmental, Health and Safety.” If you have any comments or feedback – I loved to hear it.  You can call our listener voicemail feedback line at 206-337-4769 and leave an audio comment.  You can also stalk us on twitter at twitter.com/Affygility, or follow us on Facebook by just searching for Affygility Solutions and giving us a “Like. You can also email us your comments at podcast at Affygility.com.

Alright, let’s now talk about some upcoming events.

 

 First I should mention, that coming up in April, we have several new webinars starting and you should look at our schedule at Affygility.com.  These webinars have been very well attended and we have received a lot of positive feedback on them.  In addition to our very popular webinar on Advanced Topics in Potent Compound Safety, we also have a webinar on Dermal Exposure to Active Pharmaceutical Ingredients, Global Harmonization System, Hazardous Wastes for Hospitals, Clinics, and Medical Laboratories.  Again, if any of that interests you, I would suggest that you go to Affygility.com and look at our full schedule.

Finally, as mentioned in previous podcast, I’ve been working on a podcast about the Young Guns of Environmental, Health and Safety.  So far, I’ve had over 100 participants complete the survey.  This week I will be working on tallying up the results and will have a free webinar presenting the results this coming Thursday, March 31st.  For details on the time and how to register, please go to potent compound safety.com.

 

O.k.  That does it for this week’s show.  Remember to submit your questions to our voicemail feedback line at 206-337-4769 and stalk us on twitter at twitter.com/Affygility, on Facebook by searching for Affygility Solutions and giving us a “Like”, and finally on LinkedIn by searching for Affygility Solutions. 

 

 

 

 

 

 

 

 

 

Direct download: BioPharma_EHS_Podcast_13.mp3
Category:general -- posted at: 8:26pm MST

BioPharma EH&S Podcast Episode No. 12.  Saturday, March 5th, 2011 and we have so much to talk about today, so I’m going to get right into it.

First off, I’ll briefly cover what we talked about last time in episode number 11

Main topic for today :“Creeping Featurism in Environmental, Health and Safety software”, which I’m quite certain sure will stir up some controversy.

Last time in Episode 11 we discussed the topic of “The Evolution of EHS Compliance and Operational Risk Management Software.”  Unfortunately I don’t have time to cover all the details today, but basically we covered the history of compliance software systems and tools, and where the future of EHS software is heading.  If any of that sounds like something that might interest you, I would suggest you go back to episode number 11 and listen to the whole thing.

Let’s now get into our main topic for today which is

“Creeping Featurism in Environmental, Health and Safety software”

As many of you know, this past week I was in San Antonio, Texas at the National Association for Environmental Management’s Management Information Systems conference.  At this conference, there were numerous presentations by companies that have recently gone or going through the process of implementing an environmental, health and safety management information system.  In general, the presentations were good and the organizers did a great job of keeping everything on track, but as with most conferences, the best part of the conference was the excellent conversations in the hallway with your peers and colleagues, and the opportunity to meet new people.  However, as I thought about the presentations more, in some respects, I would like to see a presentation style similar to the DEMO conference.  Most of you listening to this podcast probably have never heard of DEMO, but DEMO is conference that is held twice per year, where technology developers are selected to showcase their latest technologies in front of venture capitalist, the technology media, and other technology interest groups.  DEMO is a pay to present type of conference and their presentation requirements are fairly unique – there is no Powerpoint allowed, and you have to use a “live” system not an install that on a local machine, and you get a very short amount of time to show what your system does – I believe it’s six minutes.  This style of presentation places a lot of pressure on the solution providers to make sure that their systems are clean, fast, and easy to explain.  “Bloatware” will not survive this kind of presentation style.  I will put a link to the DEMO conference website in the show notes.

However, backed to the conference in San Antonio, based on the presentations of the environmental, health and safety software that I saw, I have the following observations.

  • First off, everybody seems to want a “comprehensive” systems that will do everything.  They want it to handle everything from accident reporting to industrial hygiene, from carbon footprint reporting to sustainability reporting.  But despite what the solution providers will tell you, this dream system doesn’t really exist, at least not in an off the shelf version.  Solution providers tend to be reacting to perceived customer needs and keep adding module after module.  While this may provide the impression of comprehensiveness, I might mention that with all this increased “comprehensiveness” comes a significant increase in “complexity” of user interfaces.  Based on the seven or eight systems that I saw during my two days in San Antonio, most of the user interfaces were very, very cluttered.
  • The second observation or take home point was, and as I believed as one of the speakers stated, make sure that your people understand that an environmental, health and safety management system, or EMS, is not about the software or your management information system.  In other words – an EMS is not equal to MIS.  The software is just a tool to support your EMS.
  • The third observation was, understand that “configuration” does not equal “customization”.  Much of the costs of implementing an environmental, health and safety software solution arise when the company insists that the system have certain features that are unique to their company.  If you want to keep costs down and ensure rapid implementation - get a system that is easily configurable and works “off the shelf”.   As soon as you start demanding customization, expect the costs to go up significantly and the time for implementation to get much longer.
  • And finally, the fourth observation was that these comprehensive systems are pricey.  If I recall correctly, at the closing presentation, based on a survey of its members, the typically budget for an EH&S-MIS system was somewhere between 100 thousand to 500 thousand per year.

So there you have my four observations 1) Everybody wants a comprehensive system that is off the shelf, 2) EMS is not equal to MIS, 3) configuration does not equal customization, and 4) comprehensive systems are pricey.

So if you’re considering selecting and implementing an EHS-MIS, I’d like to propose that you ask yourself several questions.

The first question you need to ask yourself is “Where’s the value?” When scoping out a system keep a laser like focus on the value rather than the features or comprehensiveness.  Make sure that you are creating something that serves a real business outcome and not creating “bloatware.” From my perspective, companies are attempting to track too many things that really don’t advance the value of the company.  And when I talk about “value” I don’t necessarily just mean economic value.  In one presentation, I believe the presenter indicated that when they scoped out the user requirements they initially came up with 24 health and safety tracking requirements, and 34 sustainability requirements.  Ask everyone “where are the value added measurements?”  Which of these measurements are critical for reducing operational risk, improving the profitability of the company, or reducing significant amounts of pollution or wastes?

Ask yourself “What is the end user really willing to do?”When scoping out user requirements for an environmental, health and safety management information system be very careful when listening to the end user.  In other words, don’t listen to what they tell you - watch what they do.  Instead of asking what they want, ask what they are they willing to spend their valuable time and money on.  The end user always, always wants ultimate flexibility. They want corporate colors and font, the ability to move the field input box from the left to the right, the ability to sort environmental, health and safety data by every possible way, draw every possible graph, and add custom fields at their leisure.  Please understand, that while all of this is very doable, it does come at a cost.  So, instead of asking about what features or requirements they want, ask them if they are willing to stay at work till 7:00 each Friday night of every week entering this data.  I’m quite certain that you will get your answer very soon.  Reducing complexity will improve data integrity.

Ask yourself “How can we reduce complexity?” Instead of always thinking about what features we should add, think about what we should remove instead of what we should add.  Don’t get sold on all those pretty graphs that only impress yourself and your team.  Instead think about flexibility.  If you want those pretty graphs does the system have the flexibility to dump the data to Excel and then you can spend your personal time at night creating the graph in the official corporate colors and fonts.

What single requirement do we need to do very well?Look at what the biggest EH&S challenge facing your company is, and fix that problem in a meaningful way.  Don’t worry about tracking the difference between potable and non-potable water usage when you’re having 60 occupational fatalities per year.  Fix the bigger issues first.

Ask, How long is the implementation? At the conference, one company indicated that they were 2 ½ years into implementation. What? To me that equals lots of time in meetings and paying a team of consultants many, many billable hours.  Consultants love this kind of stuff, because it means job security to them.

Ask, Who is on the selection and implementation team?EHS, IT, and Purchasing on the decision team - that’s a bad combination. What about operations? What about finance?

Ask, What defines success? When embarking on any software project understand that there’s risk involved – risks of cost and schedule overruns, and risk of creating a system that never get adopted by the end users.  According to the Standish group, in the United States, only 16.2% of software projects are completed on time and on budget.  In larger organizations, only 9% of software projects meet those goals.  According to the Standish group, the average cost over run is 189% of the original cost, and the average time overrun is 222% of the original time estimate.  According to their report, the 3 major factors that determined the “success” of the project was user involvement, executive management support, and clear statement of requirements.

What will our future workforce be like? Understand the future of your workforce and current trends, not the old.  The future of environmental, health and safety professionals that will be entering the workforce in the next 10 years are very different than the “decision makers” of today.  They are smart, comfortable with technology, used to rapid change, demand instant feedback, and are very mobile.  They have practically grown up with a smartphone such as a Blackberry, iPhone or Android in their hands, and are deeply involved in Facebook, Twitter, Youtube and LinkedIn.  Their needs, their demands will be very different from ours.  Figuring out ways to increase user engagement with this generation of environmental, health and safety professionals will be challenging for even the best of us.

In closing this part of the podcast, I’d like to say that EH&S software, can be beneficial to any company, but be you need to be very clear about your expectations.  In addition, always, always look to simplify processes, rather than making more comprehensive.  Otherwise, your risk of failure rises significantly.  Sometimes a simple and affordable environmental, health and safety software solution that works off the shelf is best.

O.k.  The does it for the discussion on “Creeping Featurism in Environmental, Health and Safety software. If you have any comments or feedback – I loved to hear it.  You can call our listener voicemail feedback line at 206-337-4769 and leave an audio comment.  You can also stalk us on twitter at twitter.com/Affygility, or follow us on Facebook by just searching for Affygility Solutions and giving us a “Like. You can also email us your comments at podcast at Affygility.com.

Alright, let’s now talk about some upcoming events.The first event is the Society of Toxicology meeting on March 6th through 10th in Washington, DC.  Dr. Joe Nieusma, Senior Toxicologist with Affygility Solutions will be attending this event, so if you would like to meet with Joe let me know.

Next, on March 11th through 15th, I will be attending South by Southwest Interactive in Austin, Texas.  I’ve been looking at the schedule of sessions and events that will be happening at South by Southwest and it is amazing.  This event has nothing to do with environmental, health and safety, but more to do with interactive technologies.

Then I should also mention, that coming up in April, we have several new webinars starting and you should look at our schedule at Affygility.com.  These webinars have been very well attended and we have received a lot of positive feedback on them.  In addition to our very popular webinar on Advanced Topics in Potent Compound Safety, we also have a webinar on Dermal Exposure to Active Pharmaceutical Ingredients, Global Harmonization System, Hazardous Wastes for Hospitals, Clinics, and Medical Laboratories.  Again, if any of that interests you, I would suggest that you go to Affygility.com and look at our full schedule.

Direct download: Biopharma_EHS_Podcast_Episode_12.mp3
Category:general -- posted at: 9:10pm MST

BioPharma EH&S Podcast Episode #11

  • Discuss: The Evolution of Environmental, Health and Safety Compliance and Operational Risk Management Software
  • Upcoming Events and Happenings of Importance to Environmental, Health and Safety professionals in the BioPharma industry.

Hello everybody and welcome back to the Biopharma EH&S Podcast, Episode #11, it's Saturday, February 26th, 2011.  And this is the podcast helping you take your environmental, health and safety program to the next level.

This next week, on Tuesday, I will be heading to San Antonio, Texas for the National Association for Environmental Management (NAEM) Management Information Systems conference which will be happening on Wednesday and Thursday, and then on Thursday of the following week I will be heading to Austin, Texas for South by Southwest.

So the first thing that we always go over is to review what we talked about in the last episode, then we will cover our main topic for today, which is "The Evolution of Environmental, Health and Safety Compliance and Operational Risk Management Software".  Then after that we will discuss important events and happenings of importance to EH&S professionals in the biotechnology, pharmaceutical, and medical device industry.

As a podcaster, having listener questions and feedback is extremely important and it would me a lot to me. So, please call our listener voicemail feedback line at 206-337-4769 with your questions regardingenvironmental health and safety software, potent compound safety, industrial hygiene, and anything else related to EH&S in the Biopharma Industry.

In Episode #10 we discussed "Industrial Hygiene in the Pharmaceutical Industry." In that discussion we talked about the strategies for managing a potent compound safety program in the pharmaceutical industry is actually similar to managing a traditional industrial hygiene program, however, the big difference is that many of the compounds have occupational exposure limits that are significantly lower than those of traditional industrial chemicals, and that you will have to place an emphasis on engineering controls in order to achieve acceptable airborne concentrations.

So, let's go ahead and move into our main topic for today, which is:

The Evolution of EH&S Compliance and Operational Risk Management Software

So what exactly is EH&S Compliance and Operational Risk Management Software?  Well that can mean many things to many different people and companies.  For some companies that are somewhat in the reactive mode - it may mean just tracking occupational injuries, accidents, and claims.  For others, for those companies that are slightly more proactice - it may mean audit finding tracking, corrective action tracking, and leading indicator tracking.  And for the more advance companies it can mean tracking sustainability efforts, and greenhouse gas reduction efforts.  It also can mean authoring and managing material safety data sheets, air emissions reporting, hazardous wastes management generation tracking, industrial hygiene data management, and many, many other environmental, health and safety program elements.

So, let's step back for a moment and talk a little about the history of environmental, health and safety compliance software, and operational risk management software.  Back in the mid-1980's when I started in the environmental, health and safety field I was working for Waste Management of North America as an Environmental Coordinator.  Back in those days I remember that the majority of EH&S tasks were done by paper, and completion of paper-based forms. I also recall that EHS professionals were largely the people with the big binders on their bookshelves containing all the company EH&S rules and programs.  At that time, at least at the entry level, personal computers in the workplace were rare.  Then as we approached the 1990's a few computers starting appearing around the office, but were pretty much exclusively limited to divisional presidents, directors, and an administrative assistant or two.  I still recall, looking out my office door, and seeing our library of federal and local regulations that covered the entire wall in one of our common areas.  Then in the late 1980's, our first safety management software system appear.  It was a DOS based system used for reporting occupational injuries, accidents, and other claims. It was basically, a workers' compensation and liability claims management system.  So, it was really an operational risk management software tool.  Still at that point, data entry into the system was primarily done by the admins, and the EH&S management would receive a printed report once per month.  As more and more people in the office begin to have dedicated computers, everyone started  to get creative in using them to manage various issues, including environmental, health and safety.  I believe the first EH&S software tool that I every developed was a Lotus 1-2-3 spreadsheet used to track employee training.

Then in 1990, the next environmental, health and safety management software tool that I recall using was a system called CMS, which stood for Compliance Management System, and as the name refers to, it was primarily a PC-based system to manage EH&S compliance tasks and requirements.  It was ugly, but it actually worked quite well.  The one challenge however, was in those days, implementation was a pain.  A team of people would come out for a week or more, review every permit, every requirement and input them by hand into the environmental, health and safety software system.

Then around 1993, I recall my first experience with the world wide web - I clearly remember that I was in the office of the IT manager who's office was next to mine, and using Mosaic we pulled up the Center for Disease Controls' website.

After that event, I remember that information technology just exploded, and in March of 1993, I attended the Global Environmental Management Initiative meeting in Pentagon City.  During that meeting, there was a presentation about integrating right-to-know information at Dupont.  It was basically centered around managing material safety data sheets.  During that same time frame, I recall seeing a presentation by Bill Sugar on Anheuser-Busch's Environmental Management System, which was originally written in Lotus Notes.  It had it's shortcomings, but with the leadership of Bill Sugar and his team of environmental, health and safety professionals they took EH&S management to a whole new level.  We then began to see environmental, health and safety software move from compliance-focused, and regulatory reporting focused to more of a total quality management approach.  With the emergence of ISO14001 and OHSAS 18001 managing data began more important.  In addition, with increase demand for corporate transparency, the need for rapid access to environmental, health and safety data became even more important.

So, that's some of the early history of environmental, health and safety software.  And were do we stand today?  Well, that vast majority of environmental, health and safety management systems are web-based.  Everyone has an email, everyone has access to a computer. Our cell phone's have more computing power than my first computer.  Most major corporations collect and report all kinds of environmental, health and safety data.  The majority of this data is readily available to anyone with a computer.

So what challenges do we face today?  First off, reducing complexity.  As a provider of environmental health and safety software, we have to realize that not every company is going to have a full-time administrator to run these complicated systems.  More features, doesn't necessarily mean better.  If you think about it, the one reason text messaging and twitter is so popular is that if you can't say it in 140 characters then you're saying too much.  Second, there's too many companies offering EHS software solutions out there, there has to be, and will be some industry consolidation.

So, what's in store for the future of environmental, health and safety software?  Well,EH&S mobile apps, like Affytrac mobile will become more important.  I also have addditional thoughts, but prefer to keep those to myself for now.

Alright, so that does it for our discussion on "The Evolution of Environmental, Health and Safety Compliance and Operational Risk Management Software"

So here's events and happening for environmental, health and safety professionals.

Next week, as previously mentioned, in San Antonio, Texas - the National Association for Environmental Management will be having its Management Information System conference.  I'll be there and would love to meet you.  Please call me at 303-884-3028 or email me at dcalhoun@affygility.com

Next on March 6-10, it's the Society of Toxicology's annual conference in Washington, DC.  I won't be there, but Joe Nieusma, Senior Occupational Toxicologist with Affygility Solutions will.  If you would like to talk to Joe, please give me a call and I can arrange it.

Then in April, Affygility Solutions has a whole bunch of environmental, health and safety webinars starting.  These include, our every popular Advanced Topics in Potent Compound Safety, our Dermal Exposure and Absorption of Active Pharmaceutical IngredientsIsoflurane Safety, and much more.  Go to Affygility.com and check out our schedule.

Direct download: Biopharma_EHS_Podcast_Episode_11.mp3
Category:general -- posted at: 10:08pm MST

 

BioPharma EH&S Podcast Episode No. 10

Note: This is the abbreviated script of the podcast, for the more detailed version go to http://potentcompoundsafety.com/?p=642

Cover what we talked about last time in episode number 9

Then I will cover our main topic for today, which is “Industrial hygiene in the pharmaceutical industry.”

Discuss upcoming events and happenings of importance to environmental, health and safety professionals in the BioPharma Industry.

Discussed the topic of “Are you an environmental, health and safety road warrior?”  Get into our main topic for today which is “Industrial hygiene in the pharmaceutical industry.”

What I’m going to talk about here is based off of a journal article written by myself, Dr. Joe Nieusma, Senior Occupational Toxicologist with Affygility Solutions, and Angela Coler of Affygility Solutions.  This article is titled “Strategies for preventing occupational exposure to potent compounds” and was published in a 2010 edition of Toxicology Mechanisms and Methods.  In that article, Joe, Angela, and I discuss that since the 1970’s, occupational toxicologists, industrial hygienists and other occupational health professionals in the pharmaceutical industry have recognized that occupational exposure to active pharmaceutical ingredients can cause unintended health effects in workers handling these substances.  In our Advanced Topics in Potent Compound Safety webinar, Dr. Nieusma, always discusses that chemical compounds that are routinely handled in the pharmaceutical industry are unique from other chemicals in that these compounds are designed to have an effect on the human body.  In an occupational setting, if an employee provides a pathway of exposure to a potent compound, there is a high probability that the compound is going to elicit the designed response.  Industrial hygienists and other occupational health professionals in the industry have responded to this hazard recognition by employing strategies for the risk evaluation and control of potent active pharmaceutical ingredients, otherwise known by the term “potent compounds.”

The strategies for preventing occupational exposure to potent compounds are very similar to any other industrial hygiene process, and consist of anticipating and evaluating the hazards of potent compounds; determining which of those process activities pose the highest risks; evaluating those risks, and finally, controlling potential exposures primarily through engineering devices.  These strategies should be applied at all stages of pharmaceutical product development including discovery, pre-formulation, initial test batches, pilot plant, scale-up, and production.  These strategies can be applied to initial discovery of a potent compound by an innovator company or to the development of a product coming off patent by a generic pharmaceutical company.

Don't go into the definition of a potent compound, refer to article

So, let’s now talk about our first strategy component, the first component is Evaluating the Hazards of Existing and New Compounds

Prior to the introduction of any new APIs into the workplace, a thorough scientific literature search on the specific or similar compounds should be conducted.  If your company is just getting started in developing a potent compound safety program, a thorough literature search should be performed on pharmaceutical products already in the company’s portfolio – either in development or already on the market.  The industrial hygiene professional needs to gain an understanding of the potential hazards of all of the company’s products. While retrieving literature and understanding the hazards may seem like a fairly simple task, for new compounds early in the development process it is often challenging to find information that is relevant to an occupational exposure scenario.  However, the primary focus should be to identify sufficient information to allow preliminary classification of the potent compound into a control banding strategy.  Much has been written about control banding in the pharmaceutical industry, so I won’t go into those details today, but would suggest you either attend one of our webinars on this topic or do some research on this subject.  I will however mention that one of the most common modification to the classification scheme is typically in the number of classification bands individual companies utilize for their products.  The number of bands that a company chooses to employ depends on the range of pharmaceutical products in the company’s portfolio and the number of control options that the company has implemented. As an example, Affygility Solutions use a 5 band scheme.

When you or your occupational toxicologist are searching for potential literature sources of information, these can originate from both inside a company and from published scientific literature.  Primary articles, can come from high quality databases from the National Library of Medicine can provide published resources on numerous chemical substances. However, for discovery compounds, the internal toxicology studies will provide the most useful information.  If the chemical entity has been on the market for a significant period of time, the literature can possibly provide all the necessary data to complete a potent compound safety classification.  Once the data has been assembled, professional judgment must be exercised to evaluate the data and determine the critical toxicological endpoints.  

Conduct Risk Assessments on All Potential Exposure Scenarios

 

After you have an understanding of the potential hazards of the compound has and a preliminary occupational exposure limit has been calculated, the occupational toxicologist or industrial hygienist should perform a detailed risk assessment.  Risk assessments are often an overlooked, but extremely important, component of a potent compound safety program.  These risk assessments will contain a number of risk factors that will define the probability of exposure. These risk factors include how the active pharmaceutical ingredient is handled, the physical form, the quantity, the frequency and duration of exposure, and several other factors. Ideally, a well developed potent compound safety program will have completed detailed risk assessments on every step of the process. Also, in addition to manufacturing processes, risk assessments should also be conducted for non-routine activities, such as emergency repair activities, spill situations, or equipment failure.  In order to appropriately conduct a risk assessment, a number of departments will need to be involved.  These departments can include: industrial hygiene, occupational toxicology, occupational health, and operations.

Strategy Component 3:  Evaluate Potential Exposures

 

After you have completed risk assessments, a risk-based monitoring strategy will need to be developed.  Exposure assessment strategies such as those used for other industrial hygiene purposes are fine.  But, briefly, exposure assessments are utilized to identify the need for engineering controls or in the case where engineering controls alone are not adequate to control occupational exposure, if personal protective equipment is required as an additional means of protection.  Data from an exposure assessment will determine the level of containment achieved and if other means of controlling exposure are required.

When conducting air monitoring for potent compounds, it is frequently the case that air sampling and analytical methods will not be available and will need to be developed by specialty industrial hygiene analytical laboratories.  We go into a lot more detail on this subject in our webinars, so I won’t discuss it here.  However, during the interval of method development for a potent compound, the integrity of the containment strategy can be tested.  It is a very common practice in the pharmaceutical industry to use either lactose or naproxen sodium to perform surrogate monitoring on the equipment prior to inclusion of the more potent compounds.  This practice is typically called performing containment validation studies.  Affygility Solutions has significant experience in performing these types of studies, so if you need more information please don't hesitate to contact us.  The data from these evaluations can then be used to determine how the containment strategy will perform when the potent compound is actually introduced.

After you receive the exposure assessment results, the industrial hygienist will need to carefully evaluate the data and compare to the field notes to determine the activities and operations that contribute to increased exposures. Exposure assessments are a critical tool for performance verification of engineering controls.  Operator effects are numerous.  Even the most sophisticated engineering controls can be ineffective due to poor operator technique or failure to follow established procedures. It’s been my experience that a single instance of inappropriately using a compressed air hose to remove spilled dry API from the top of a container can result in an 8-hour time weighted average exposure that is 400% higher than other who did not use a compressed air hose.  Training is critical to decrease or eliminate variability in operator technique.  Consistent techniques, attention to detail, and proper use of the available engineering controls is critical in preventing occupational exposure to potent compounds

Implement Risk Management and Control Measures

 

The primary focus of a comprehensive potent compound program is to prevent occupational exposures through effective process containment.  When handling highly potent compounds, containment must be provided during all steps in the process.  Typical containment devices include the use of downflow booths during weighing or dispensing activities, the use of high containment or split butterfly valves during product transfer between containers, local exhaust ventilation near dust generating activates, closed systems, vacuum transfers, and the use of isolators to enclose the process.  Engineering controls need to be a workable design, ergonomically correct, and user friendly or they will quickly be relegated to the backroom by operators.  The operator interface is one main aspect that is controllable.  Minimize operator interaction in a process, and the exposure potential will also be minimized.

In addition to engineering controls, other risk management strategies may need to be utilized.  These can include administrative controls such as compound-specific hazard communication training and product-specific medical surveillance.  However, these aspects cannot be considered as a substitute for the previously mentioned engineering controls.  Other examples of administrative controls include time limits for operator exposures, gender restrictions, biomonitoring protocols, and process changes to eliminate operator variability.  The use of personal protective equipment should only be used as a tertiary means of exposure control.

Strategies for preventing occupational exposures to potent compounds require that all elements be considered.  Failure to control exposures to potent compounds can result in costly program missteps, delayed production schedules, or potentially hazardous exposures to workers.  A comprehensive potent compound program will have contributions from occupational toxicology, industrial hygiene, safety, engineering, and operations.  The bottom line is employee safety and increased productivity.

O.k.  The does it for the discussion on “Industrial hygiene in the pharmaceutical industry. If you have any comments or feedback – I loved to hear it.  You can call our listener voicemail feedback line at 206-984-3214 and leave an audio comment.  You can also stalk us on twitter at twitter.com/Affygility, or follow us on Facebook by just searching for Affygility Solutions and giving us a “Like. You can also email us your comments at podcast at Affygility.com.

Alright, let’s now talk about some great upcoming events.

The first event is the National Association for Environmental Management MIS Conference to be held on March 2nd and 3rd in San Antonio, Texas.  I will be attending this event and showing off our new mobile EHS app, so if you would like to meet up with me, please feel free to call the listener voicemail feedback line and let me know that you’re going to be there.

The second event is the Society of Toxicology meeting on March 6th through 10th in Washington, DC.  Dr. Joe Nieusma, Senior Toxicologist with Affygility Solutions will be attending this event, so if you would like to meet with Joe and discuss potent compound safety, so let me know.

Next, on March 11th through 15th, I will be attending South by Southwest Interactive in Austin, Texas.  I’ve been looking at the schedule of sessions and events that will be happening at South by Southwest and it is amazing.  This event is going to be “off the chain”. If you don’t know what that means “Google it” and find out.

I should also mention, that in April, we have several new webinars starting and you should look at our schedule at Affygility.com.  These webinars have been very well attended and we have received a lot of positive feedback on them.  In addition to our very popular webinar on Advanced Topics in Potent Compound Safety, we also have a webinar on Dermal Exposure to Active Pharmaceutical IngredientsGlobal Harmonization System, Hazardous Wastes for Hospitals, Clinics, and Medical Laboratories.  Again, if any of that interests you, I would suggest that you go to Affygility.com and look at our full schedule.

Finally, I’m starting to prepare for a podcast on the Young Guns of Environmental, Health and Safety, and I need several volunteer guests.  If you’re between the age of 25 to 34, and work in the environmental, health and safety field please send me an email if you’re interested in participating.  My email address is dcalhoun@affygility.com

O.k.  That does it for this week’s show.  Remember to submit your questions to our voicemail feedback line at 206-984-3214 and stalk us on twitter at twitter.com/Affygility, on Facebook by searching for Affygility Solutions and giving us a “Like”, and finally onLinkedIn by searching for Affygility Solutions.

 

Direct download: Biopharma_EHS_Podcast_Episode_10.mp3
Category:general -- posted at: 9:51pm MST

 

Biopharma EHS Podcast Episode #9

Opening

So for today, first off, I'll mention what we discussed last time, then we I'll cover our main topic for today - which is how to be a road warrior of environmental, health and safety, and then finally, I will mention important upcomings and happenings that are applicable to environmental, health and safety professionals in the Biopharma industry.

So, in our last podcast, episode 8, I discussed the future of EH&S.  Now, when I'm talking about the future, I'm not talking what's on OSHA's regulatory agenda for this year or next, I'm talking about 15 to 20 years ahead.  In that episode, the key issues and technologies that I personally forecasted and will impact environmental, health and safety professionals include the untethering of the workplace, the widespread use of mobile phone applications for environmental, health and safety, industrial hygiene, environmental compliance and more; managing environmental, health and safety in crowdsourcing; just-in-time EHS training; conferences becoming much more social; and finally "occupational toxicology on a chip".  If any of this interests you, I would strongly suggest that you go back and listen to the entire episode.

Let's now go ahead and move on to the next topic, and get started with how to be an effective road warrior of environmental, health and safety?

So what exactly is a Road Warrior?  Well, a road warrior is typically, is typically, thought of as a person that travels frequently on business.  So far, in my lifetime, I've seen environmental, health and safety professionals that traveled anywhere from once a quarter to provide environmental, health and safety compliance support to facilities under their control, to those that left home on Sunday afternoon and didn't returned home till Friday evening.  These EH&S professionals included internal auditors, contract manufacturing auditors, consultants, and EH&S managers that were responsible for managing multiple facilities throughout the world.  On the extreme end of things there are some professionals that travel 250,000 air miles per year.  To put that in perspective, that's approximately one roundtrip flight from Denver to India per month.

So if you're a Road Warrior of EH&S, how do you make the best out of this situation where you are always gone away from the office?

First off, being an effective EHS Road Warrior starts well before you think about going to the airport and requires careful planning.  When you travel a lot you need to develop a routine.  To the extent possible, try to schedule your trips at the same time every month and then block them out on your calendar. Plan trips carefully and at least two months ahead.  Make sure you have a way to compare your business calendar with your personal calendar.  After all you don't want to schedule a trip and then realize that it's conflicts with important life events.

Next, you will also want to get the right kind of luggage, the right kind of laptop computer case, and other travel accessories.  Look for luggage with lots of outside pockets to stash away all your gear.  True Road Warriors hardly ever check luggage.  It's just not worth the delay waiting to check/pickup your bags, and the risk of having your luggage lost.  You may also want to arm yourself with a really good set of headphones.  I personally use a set of Bose noise-cancelation headphones and they are great the next time you have a screaming baby sitting next to you.

If you drive your own car to the airport, try to always park in the same general area.  This will reduce the chance that you will forget where you park your car.  This is especially true when you start having back-to-back trips.  If you can't always park in the same place take a picture of the parking lot location sign with your smartphone's digital camera.

When traveling frequently to the same location, whether as a routine visit or for a project, try need to find a good hotel that you like and make a habit of staying there.  You want it to feel like home. And, if you check into a hotel and walk into the room and it's crap, don't be shy and afraid to go to the front desk and say "I'm going elsewhere."  I remember many years ago I had to perform some emergency response training in the middle of nowhere in Georgia.  I got to my hotel and there where roaches running across the floor and the toilet was all yellow urine stained.  I didn't last 3 minutes till I went to the front desk and said bye.  This doesn't mean you have to be a jerk, it just means you need to have personal standards and try to maintain them while traveling.  The typical things I look for when selecting a hotel: first off, it needs to be close to the facility that I'm visiting.  I hate, I absolutely hate, having to wake up super early just to fight traffic to get to the facility, 2) it better have a decent in-hotel workout facility.  If you're traveling frequently it is extremely important that you maintain an exercise routine - otherwise, airplane and airport food will cause your health to decline rapidly and you'll be dead before your 55.  3)  In-hotel bar or restaurant with free Wi-Fi and friendly staff.  Avoid the feeling of isolation and loneliness by getting to know the people that work there, especially the front desk people and the bartender.  Hey you never know, you might be able to teach the bartender a thing or two about potent compound safety.

Join the Loyalty Programs

Take advantage of every customer loyalty program you can envision.  Frequent flier programs are no brainer, especially if your company allows you to personally accumulate the miles.  As a consultant in potent compound safety, occupational toxicology, and industrial hygiene for pharmaceuticals, I have received many free flight tickets that I've used for my family to travel places.  Don't use the frequent flier miles for yourself or you won't get the miles for the trip. Use them for your family. Another benefit of enrolling in the customer loyalty programs is getting miles for elite status which may entitled you to early boarding and free upgrades.  For rental cars, again it's a no-brainer, nothing is better than by-passing the long lines at the counter and heading straight to your car. Keys in the ignition, show the guy your license, and you're gone.  For hotels, most hotels have sophisticated databases that know how many times that you have stay there and if you make it to a certain level they will jump through hoops for you.  Again, another reason to stay at the same place.

I should mention that as you join customer loyalty programs, you will accumulate a lot of cards - don't put them in your wallet or purse. Instead, go to to one of those leather store in the airport or mall, and buy one of those long leather wallets where you can stash all your loyalty cards.  If you can, stash a way a couple of extra twenty dollar bills in there as well.  You don't know when you might need it.

If travel more than twice a month, you should consider joining one of the airline clubs.  Depending upon the airline, you can get free wi-fi, comfortable seating, snacks, and free drinks.  You'll be thankful you joined the day you get delayed for several hours.

Take Advantage of Technology

When you travel a lot, you have to be organized and travel light.  Even if you have to pay for it out of your own pocket, get a great smartphone and a light laptop.  In addition to a decent phone, your smartphone should have a great GPS mapping system, otherwise you're going to get lost, a digital camera, a calendar system, a digital music player, and the ability to install apps.  Carry as few of books or papers as you can or you're going to hate life carry all this crap through the airport.  Especially, with the way security is these days.  So, let's just assume you're not big on listening to music. That's o.k., then listen to podcasts, in addition to the Biopharma EHS podcast, there are many other great podcasts or digital books out there. Get with the program and use technology to your advantage.  Use digital technology to record notes. Programs like Evernote work great for recording all the tidbits of information.  For compliance related items such as regulatory compliance tasks and corrective action software, I use Affytrac.  In order to be an effective road warrior, you must be able to retrieve information quickly and without saying "Uhh, it's back at the office."  Remember that effective Road Warriors has no office.  Your office is in your bag on your shoulder and on your phone.  Another benefit with recording compliance related tasks digitally is that if your bag or laptop gets lost or stolen, it's simply a manner of changing your password and all is good.

While we're on the subject of apps you might want to check out Affytrac Mobile - a simple and affordable way for you to manage all your compliance and corrective action management system requirements from the convenience of your smartphone.  If you have questions about Affytrac Mobile, give me a call on my mobile phone at 303-884-3028.

Still on the subject of apps, I should mention that restaurant apps such as Yelp or Urban Spoon are also great for finding that great restaurants. You can use location-based apps such as Foursquare or Gowalla to check-in and keep a virtual "journal" of your trips. Make it fun and don't worry about oversharing.

Get to know the Local Environmental, Health and Safety Community

Chances are that if you're visiting a specific facility frequently, that the people you need to meet can't be available for the entire time that you're there.  This is especially true if you're there more than once a month.  Also, in general, these people will likely have family obligations and having to entertain you every evening while your there gets old. Don't wear out your welcome and find something else to do, but at the same time make good use of your time.  With a little bit of research, you might find that the local chapter of the American Industrial Hygiene Association, or the American Society of Safety Engineers, or some other professional organizations will either have a lunch or dinner meeting at certain times of the month.  Schedule your routine trips for those times and attend those meetings.  In addition to meeting new people, you begin to get a deeper understanding of the local regulations.

Stay Connected Back Home

O.k. you may be so old school that your idea of technology adoption is using a mechanical pencil - get over it and learn some new stuff.  The world is not going to rewind to your style and you have to learn new skills or you will get replaced.  You should also consider that maybe, just maybe, that those evening hours alone in the hotel bar or in your room are just the time to learn them.  If you're a Road Warrior you really need to be on LinkedIn and Facebook in order to stay socially connected to the the new professional friends that you meet while on the road and the family you have back home.  Don't be afraid to post pictures of that really cool castle that you drove by when you where going to a potent compound safety review meeting in the middle of Germany.  People love that stuff.  They want to see you as a real person, not some robot.  While I'm on that subject you can connect with me on LinkedIn and Facebook.  Please invite me to be a connection on LinkedIn and "Like" us on Facebook.  In either case just search for "Affygility Solutions" and you will find us.

Go with the flow

Traveling on business is full of unexpected things. No need to stress out about it, and be nice to people.  During my travels, I've run into more than my fair share of jerks.  You know the ones that act like they are the only ones that matter - yelling at everyone that crosses their path, cutting in lines, and just about every rude act you can image.  My feeling, if you hate traveling that much find another job.

Well, that does it for the Road Warrior segment of today's episode. I'm sure many of you out there have lot's of other great suggestions, so feel free to email at dcalhoun@affygility.com or call them in to me.

Next, let's go over some important events and happenings that may be of interest to environmental, health and safety professionals in the Biopharma industry.

Discuss events

 

Direct download: Biopharma_EHS_Podcast_Episode_9.mp3
Category:general -- posted at: 2:49pm MST

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Biopharma EHS Podcast Episode #8

 

Oh yay everybody, that’s right.that’s right..how are yay?  Folks it’s Tuesday, February 1st, 2011 and that’s right, we’re back  we’re back for another episode of the BioPharma EH&S podcast.

 

So what’s on our agenda for today? Our agenda for today on the Biopharma EH&S podcast is the following.  AS ALWAYS  I’ll briefly cover what we talked about last time , then I’ll jump right into a discussion on the Future of Environmental, Health and Safety, and then,  and then, we will then cover events and happenings of interest to environmental, health and safety professionals in the biopharma industry.  So, without further ado let’s get after it.

 

Alright, in the last episode – episode 7 our main topic was management commitment and involvement – how to obtain and sustain it.  In that episode I indicated that one of the most important things to consider  to consider, is to know exactly what you want  and try to understand what they want and the important issues on their plate.  So, if this is a topic that interests you, I would strongly suggest that you go back and listen to episode 7.

 

O.k. folks  our next topic for today is the future of environmental, health and safety.  So, looking ahead  looking ahead at the environmental, health and safety  profession, the field, what’s going to happen in the next 10 – 15 years. Let’s call it EH&S 4.0  Yeah that will work – let’s call it EH&S 4.0.  As most people know making predictions 10 -15 years out is pretty tough to do.  In most cases we don’t do a very good job of predicting want is going to happen week.  And we always run the risk of some disruptive technology or issue happening that could cause some sea change of activity, something we didn’t think of, if you will, in another direction.  But let’s go ahead and give it a shot based on trends that are occurring today.

 

The trends that I will be talking about center mostly around three main areas – technology, regulatory, and societal.  The first trend , the first trend that will have a significant impact on all environmental, health and safety professionals is what I call:

 

The Untethering of the Workplace

 

In the past, the workplace,  the workplace as we know it, was traditionally a fixed location where everyone would typically work a somewhat fixed set of hours and days of the week.  When the economy in the U.S. was primarily driven by industrial manufacturing this made sense,  but  but as the U.S. economy shifts more to a knowledge-based economy, the added overhead expense of a fixed office space no longer makes economic sense.  In addition, communication technologies have improved to the point where it is no longer necessary to have everyone in the same physical location to effectively work together on a project.  As an aside, I know a pharmaceutical company that uses Halo Collaboration Studio by HP and , in a sort of Star Wars like fashion you feel like you have Obi-Wan Kenobi sitting next to you.   So, being in the same physical space is no longer necessary.  Therefore,  therefore, as companies continue to seek out the best talent in the world, that talent may come from anywhere in the world.  Sure, for research and development centers we will still need fixed locations, but even then, but even then, research clusters are becoming so predominant that sharing of workspaces on as needed basis will become more popular.  This will present unique, unique challenges for traditional occupational health and safety programs in determining who is the host employer, this will present challenges in conducting EH&S training, and as I will talk about later you will see an explosion in just-in-time training.

 

The second major trend I would like to call “There’s an “App for that”

         I’m not sure how many of your have a smartphone, but look for a significant increase in smartphone applications or as they call it “apps” for industrial hygiene, environmental compliance, health and safety.  Before I get into a lot of detail, maybe  may I should first define what is a smartphone  A smartphone is a mobile phone that offers more advance computing power and connectivity than a traditional mobile phone.  Smartphones typically are equipped with a mobile phone, web browsing capabilities, a global positioning system (a.k.a. GPS), a digital camera, and the capability to run small application programs know as “apps”.  These apps are typically digitally downloaded from the Internet for little or no costs.  The ones that are free typically come with ads, the ones that aren’t free don’t.  As of today, there already are apps for games, mapping, checking in to physical locations, getting reviews on just about anything, and much more.  In the future  in the future your smartphone will become an industrial monitoring device – handling all sort of things - chemical, biological, and physical exposure information. Monitoring for potent compound safety won’t be an issue, you will just program the molecule into your app and woala, instant monitoring.  Even today, even today, my smartphone – which is an iPhone - has a sound level meter app.  I’ve compared it’s reading to those measured by sound level instruments costing hundreds of dollars more and it’s relatively close.  Technology will only get better.

 

In addition to Apps, RFID tags or similar technologies will be embedded in your phone to make it location aware.  Filling out information on the location of industrial hygiene monitoring will no longer be necessary – your smartphone will know. Heck, industrial hygiene instrumentation should already have these tags built in – it’s not that difficult.  For those of you that personally know me – I do a lot of snow skiing in the winter.  My ski pass has a RFID tag built into it and tracks every lift I boarded, and how many vertical feet, ski days and runs that I skied.  It’s not that hard.

 

On the environmental side, there will be complete data collection of facility inputs and outputs that will all be readily available and controllable on your smart phone.  No longer will environmental professionals have to spend countless hours collecting data on hazardous waste generation, electric utility and water usage, and solid wastes generation.  All this data will become available real-time and  at your fingertips on your smartphone.

 

We haven’t  we haven’t even, even to begun to see the potential use of these devices.  Here at Affygility Solutions we recently released Affytrac Mobile – a cross platform compliance management software web app that helps busy environmental, health and safety professionals manage their programs across multiple facilities, languages, and time zones.  Look for more great things from Affytrac, including potent compound safety on the go.

 

O.k., so that covers, there’s an App for that.  The next main trend I’d like to discuss is Managing health and safety of Crowdsourcing

           

So what the HECK is crowdsourcing?  Well, crowdsourcing is the act of outsourcing tasks , outsourcing tasks traditionally performed by employees or contractors to an undefined large group of people through an open call. I know , I know that there are many of you that are saying – “well we’re different, we’re different, confidentiality issues and the intellectual property issues will prevent this”, regardless of those issues it WILL happen, IT WILL HAPPEN – because the knowledge of the crowd will be greater than anyone company.

 

So with crowdsourcing, , with crowdsourcing, I might ask who will be the employer?   Who will be the one responsible for the health and safety of the as we may call it “the crowd.”  Think about it – this will be a challenge.

 

Just-in-time EHS training

Along with the end of the traditional workplace and the increase in crowdsourcing, methods to provide the required environmental, health and safety training in a just-in-time fashion will be necessary.  This can easily be done for those training requirements that are primarily information transfer, but what about those activities that require a hands-on component?

 

Conferences will become much more social

            Conferences as we know it will be a thing of the past.  Most environmental, health and safety professionals know that the real experience and knowledge learning from a conference doesn’t come from the speakers – most speakers aren’t that great – the real knowledge comes from the crowd – from the attendees themselves – the ones in the hallway.  As I was writing this article I had, I had to ask myself “Is there such a thing as a Certified Social Hygienist?” and what the heck I found a link to: Social Ergonomics

            http://www.mydutchdream.com/svh-social-hygiene-certificate/

 

I’ll post the link in the show notes – so check it out.

 

The final trend  the final trend that I would like to present is what I’d like to call “Toxicology on a chip.”  We will see , we will see in the very, very near future, the ability for a company to put a small amount of a research compound on a computer chip and have all the occupational toxicology information we could possibly need – and it will categorize, classify - whatever information we need.  Why do I believe this?  Because of the market  and the market drives innovation.  Today – it’s too expensive  too time consuming for companies to conduct all the necessary tests for drug safety, potent compound safety classification, IATA and DOT classification, REACH, GHS information and many other requirements.  In the future – put it on a chip – print the potent compound safety classification report and the MSDS.

 

So folks, that does it for the Future of Environmental, Health and Safety.” If you have any questions or comments – please call our listener voicemail feedback line at 206-984-3214.  That’s 206-984-3214.

 

O.k. Let’s now discuss events, events and happenings – you know – the things that are important to environmental, health and safety professionals – the things that make you look forward to doing your JOB.

 

The first event is the National Association for Environmental Management – MIS conference in San Antonio, Texas – yay, that’s right, San Antonio, TX on March 2nd and 3rd.  I’ll be there talking up Affytrac Mobile.  If you would like to hook up with me – please call me at 303-884-3028.

 

The next event is South by Southwest – oh yay major event.  I was at the pre-party in Boulder, Colorado last night and the host said that last year there was over 14 thousand people there.  Again – call me – let’s meet.

 

Alright, we’re nearing our time limit for today, so I need to end today’s session.  As always you can stalk us on twitter at twitter.com/Affygility, connect with me on Linkedin, or Like us on Facebook by searching for Affygility Solutions.

 

That does it for this week’s podcast – see you next week.  Please call our listener voicemail feedback line at 206-984-3214.  Have a great rest of the day.

 

 

Direct download: Biopharma_EHS_Podcast_Episode_8.mp3
Category:general -- posted at: 8:32pm MST

Management Commitment and Involvement - How to obtain it and sustain it for your EHS Program.

Introduction.

 

Review last time.

 

Main topic: "Management Commitment – how to obtain and sustain it.”

 

Upcoming events and happenings of importance to environmental, health and safety professionals in the BioPharma Industry.

 

Important announcement to talk about and I’m very excited about this, and I believe you will be too.

 

Episode 6 we discussed some of key regulatory agenda items for 2011.  Those items on OSHA’s regulatory agenda and having the most impact on the Biopharma industry are I2P2 or injury illness and prevention programs, and the pending finalization of the revisions to the hazard communication standard.

 

 

Key parts of I2P2 are likely to be management commitment, employee involvement, and hazard identification.  OSHA has indicated that this is their key regulatory agenda item for this year.  If you want more details on that discussion, I would suggest that you go back to Episode 6 and listen.  You should also stay tuned to the BioPharma EHS podcast for updates on I2P2 in future episode.

 

 

We then discussed, how OSHA was indicating that they hope to have the revised hazard communication standard that incorporates the global harmonization system elements into the standard completed by August of this year.  I did mention in that podcast, that these changes will require significant changes to material safety data sheets, and package labeling.  Which also means that you will have to update your written program, your training programs, and re-train employees.  Again, I would suggest that you go back to Episode 6 and listen in.

 

Well, the discussion on I2P2 and management commitment, leads us into our next topic - Management Commitment – how to obtain it and sustain it.

 

Often hear EHS managers state, “If I just have management commitment. If I just have management involvement.  Our progress would be so much better.”  Well, first off, any experienced environmental, health and safety professionals knows that “yes” management commitment and involvement is a critical component to a successful EHS program, but as I always tell EHS managers, be careful what you ask for and know exactly what your asking. 

 

Because when you start asking for senior management to be deeply involved in your program, along with that involvement comes a significant increase in accountability and a lot of work on your part.  And if your strategies, your goals, your objectives, don’t deliver on their promises – then senior management may be looking carefully at your ability to make strategic decisions and execute them.

 

So, before you start asking for their involvement you need to know what you want and what they want. 

 

·      First off, gain a solid understanding of what your company does, the key strategic goals for the next several years, and gain an understanding of their current business cycle – is the business in a rapid growth mode or downsizing mode?  If often surprises me, how few environmental, health and safety professional understand the company that they work for in terms of strategic direction, product and service offerings, and the overall business.

·      You also want to understand who the key influencers in the organization are and why? – who has the ear of the CEO? Who does the CEO listen to?

·      Second, understand the language of the CEO.  It’s been my experience that you can tell a lot about the type of language that they want to hear by understanding their education and background.  Prior to becoming a CEO was their experience in finance, sales and marketing, operations, or science?  In the biotech industry, it’s very common to have CEOs with a science background.  I’ve heard that in the past several years this has been changing, but if science is their language, then whatever strategies that you propose better speak the language of science and be about furthering the science of the company.

·      Once you have some understanding of the company and the background of some of its senior management – pick a few strategic targets where you can involve senior management and get some early success.  One example is drafting an overall corporate environmental, health and safety policy and getting it endorsed by senior management.

·      Next what visible, actionable items do you want management to be involved in?  In the biotech/pharma industry several things that I’ve seen that have work well is at least one senior manager being present in all safety committee meetings.  Ideally, it should be on a rotating basis. At first it may be intimidating for the staff level employees, but it does show the employees that management is willing to spend their time on safety.  One important point here – make sure you have prepared and distributed an agenda ahead of time, and have defined start and stop times.  This can’t be an ad hoc meeting.  Another example of management involvement is senior management participating in walk-through inspections of laboratories and manufacturing area.  I should mention an important point here – make sure that your senior managers are wearing all the appropriate personal protective equipment such as safety glasses, lab coats, and whatever else your company requires.  Nothing causes an EH&S programs to lose credibility more than senior managers going through work areas without the proper protective equipment.  I always can tell the company’s that have developed strong EH&S programs when annual reports have photos of executives in the lab, and they are always wearing their PPE.  Why is that so rare?  Well, taking professional photos of people wearing safety glasses is a real trick.  Because you get a lot of reflection and glare off the lens, professional photographers don’t like them and don’t want to spend the extra amount of time to get it right.

·      After you have decided on one or two things you would like to propose that senior managers be involved in, setup a meeting with the highest ranking member of management that you can get access to.  If it’s the CEO – great! If it’s the site head – that’s o.k.  But regardless of who you’re attempting to get access to – you may want to keep your direct supervisor informed or they might get blindsided.

·      Prior to meeting with them.  Make sure you have a plan on what you would like to discuss.  One page of bullet items is fine.  Stay focused and don’t get off topic, unless they want to discuss other issues.  Be open to their suggestions. They may be better than yours.  You should also be careful, not to overstay your welcome or future meetings with them will become difficult.

·      O.k. now that you have proposed some ways for managers to be engaged, what measurements are you going to keep to ensure progress in the right direction.  Without some kind of meaningful measurement you won’t be able to sustain your efforts.  Management wants to see that however they spend their valuable time is resulting in progress for the company. You likely will need several metrics and a combination of leading and lagging indicators.  Make sure your metrics are credible.  Software tools like Affytrac, our proprietary compliance management software, can be extremely helpful in tracking completion of actions..

·      Finally, now that you have their attention, it is your responsibility to provide updates to senior management. Use metrics as previously noted, as well as other important items and achievements.  EH&S reports don’t always have to be always negative news. Be sure to mention the things that are going right.  Focus on progress. Keep your report short and condensed down to 1 or 2 pages.  Use graphs where possible.  Comparison graphs are great.  Management is used to looking at these types of graphs.  These reports should be provided at least quarterly.

·      After you have gain the confidence and trust of senior management, and you have a few solid systems in place, you can further advance the progress of the EH&S program by establishing an executive level EH&S committee.  While this may be a stretch for some companies early in the development of their environmental, health and safety program, it is something to aim for.

 

So, yes management commitment and involvement is key.  If you’re an EH&S professional working full-time at a company, then there has already been some level of commitment demonstrated just by allocating a full-time position to handle these issues.  But, there are also some simple things that you can have senior management be involved. Take some small steps and you will see some progress.

 

O.k.  The does it for the discussion on management commitment. If you have any comments or feedback – I loved to hear it.  You can call our listener voicemail feedback line at 206-984-3214 and leave an audio comment.  You don’t need to leave your last name or anything like that. You can also email us your comments at podcast at Affygility.com.

 

Alright, let’s now talk about some great upcoming events.

 

The first event is the National Association for Environmental Management Conference to be held on March 2nd and 3rd in San Antonio, Texas.  I will be attending this event, so if you would like to meet up with me, please feel free to call the listener voicemail feedback line and let me know that you’re going to be there.

 

The second event is the Society of Toxicology meeting on March 6th through 10th in Washington, DC.  Dr. Joe Nieusma, Senior Toxicologist with Affygility Solutions will be attending this event, so if you would like to meet with Joe let me know.

 

Next, on March 11th through 15th, I will be attending South by Southwest Interactive in Austin, Texas.  This is going to be an exciting event and I look forward to hooking up with my good friends from E-Webstyle. They are the "A" team of Search Engine Optimization from Houston, TX  I’ve never met them face-to-face, but we have known each other virtual for several years now.  I look forward to meeting them in person.

 

I should also mention, that in April, we have several new EHS webinars starting and you should get out our schedule at Affygility.com.  These webinars have been very well attended and we have received a lot of positive feedback on them.  Also for those of you that are Certified Industrial Hygienist, you get 1.5 certification maintenance points for completing all 5 modules of the Advanced Topics in Potent Compound Safety webinar.

 

Alright, now for some very exciting news.  Just yesterday, Affygility Solutions announced the launch of Affytrac Mobile.  We are extremely excited about this innovative product and how it makes managing compliance programs so easy, and from the convenience of your smartphone.  Affytrac Mobile is the first fully functional environmental, health and safety mobile phone app.  Affytrac Mobile works from your iPhone, iPod touch, Android devices, and certain Blackberry Smartphones.  Check it out by going to Affygility.com.  We will be having a webinar going over the features of Affytrac Mobile this next Monday, January 31st, 2011 at 9:30 a.m.  The webinar should last approximately 30 minutes.  Please go to Affygility dot com to register for this free webinar.

 

Remember to submit your questions to our voicemail feedback line at 206-984-3214.  You can also stalk us on twitter at twitter.com/Affygility, on Facebook by searching for Affygility Solutions and giving us a “Like”, and finally on LinkedIn by searching for Affygility Solutions.

 

 

 

 

Direct download: Biopharma_EHS_Podcast_Episode_No._7.mp3
Category:general -- posted at: 11:01pm MST

I2P2 and GHS - important OSHA regulatory issues for 2011.  In this episode of the BioPharma EHS podcast, Dean M. Calhoun, CIH - President and CEO of Affygility Solutions discusses two of OSHA's regulatory issues for the calendar year 2011 that will effect the biotechnology and pharmaceutical industry.  The first issue is OSHA's Injury and Illness Prevention Program, and the second is the Global Harmonization System for Classifying and Labeling Chemicals.

In you have a question regarding an environmental, health and safety issue please call our listener voicemail feedback line at 206-984-3214 or contact us online.

Direct download: BioPharma_EHS_Podcast_Episode_6.mp3
Category:general -- posted at: 8:24pm MST

In this episode of the BioPharma EHS Podcast, the top 10 OSHA violations in the biotechnology and pharmaceutical industry are discussed by Dean M. Calhoun, CIH, President and CEO of Affygility Solutions.  These common violations include the respiratory protection standard, hazard communication, lockout/tagout, machine guarding, electrical, walking surfaces/space, and occupational exposure to hazardous chemicals in laboratories.  In order to avoid these types of violations, companies of all sizes should implement a compliance management software solution.

Direct download: Episode_5_main.MP3
Category:general -- posted at: 8:46pm MST

Occupational health and safety never takes a vacation.  In this episode of the BioPharma EHS Podcast, Dean M. Calhoun of Affygility Solutions discusses the problem with having an environmental, health and safety program that relies heavily on one person, and he offers advice on how to build a sustainable program that has bench strength.

Other announcements include:

The upcoming Dermal Exposure and Absorption of Active Pharmaceutical Ingredients Webinar

The upcoming Advance Topics in Potent Compound Safety Series webinar

The National Association for Environmental Management (NAEM) Management Information Systems conference in March, 2011.  Affygility Solutions will be there, and if anyone has questions about Affytrac - the environmental, health and safety compliance management software tool for the life science industry, please stop by.

South by Southwest Interactive Conference in mid-March 2011.

Direct download: Episode_4_Occupational_Health_Safety_Never_Takes_a_Vacation.MP3
Category:general -- posted at: 9:21pm MST

Call 206-904-3214 for our listener voicemail question and feedback line.  In this episode, Dean M. Calhoun, President and CEO of Affygility Solutions discusses how to become an environmental, health and safety rockstar, and has an interview with Joseph Logan, President of Global Advisors.  In this interview, Joseph discusses the amount of waste that occurs in the implementation of information technology projects, and how to avoid some of those pitfalls.  Dean also gives a shout out to Chris, Paul, and Chuck over at E-Webstyle.

Direct download: Episode_3_compliance_management_software.mp3
Category:general -- posted at: 3:52pm MST

Call 206-984-3214 for our listener voicemail question and feedback line.  This line is open 24 hours per day.  Questions regarding potent compound safety, occupational toxicology, industrial hygiene, containment validation, compliance management software, etc. in the biotechnology, pharmaceutical, and medical device industry are appropriate.  Please limit your questions to less than 3 minutes.

In this episode of the Biopharma EHS podcast, Dean Calhoun, CIH of Affygility Solutions, discusses the following:

The blog post "Potent Compounds - 7 things that every environmental, health and safety professional should know."  This was an article written by Dean several months ago and posted on the Affygility Solutions website.

A telephone interview with Dr. Joe Nieusma, Senior Occupational Toxicologist with Affygility Solutions, regarding the categorization of potent compounds.

Upcoming events, including Affygility Solutions Unplugged- Foster City.  This event will be held at the Club Bistro inside the Crowne Plaza Hotel in Foster City, CA on December 14th, 2010 from 5 - 7 p.m.  Come meet Dean Calhoun of Affygility Solutions.  He will be wearing the gray long sleeve shirt with an Affygility Solutions logo over the pocket.

Direct download: BioPharma_Podcast_Episode_2.mp3
Category:general -- posted at: 8:20pm MST

BioPharma EH&S podcast episode 1
December 6th, 2010
Hello everyone
welcome to the inaugural episode of BioPharma EH&S podcast, my name is Dean Calhoun and this IS THE podcast where I will discuss environmental, health and safety issues affecting the BioPharma Industry.
I’m here to help answer any questions you may have regarding:
I’ll talk more about that later, how you can submit questions to the podcast.
Well today, we have a lot to tackle today so let’s get started.
One of the first things that I’d like to do, is at the beginning of each podcast is tell you the different topics that I plan on covering in this particular episode.
So, the first thing I’d like to cover today is the general format of this podcast, and how YOU can submit questions or feedback to this podcast.
Secondly, I’ll cover the type of audience that this podcast is intended for.
Then, I’ll cover challenges that environmental, health and safety professionals in the biopharma industry face.
How to survive a regulatory inspection
And finally we will end the podcast by discussing any upcoming events of interest, and the main topic we will be discussing in the next episode.
So let’s get started with the General Format that each episode will follow.
1.  ~30 minutes long
2.  Start out with brief overview
3.  Once a week
4.  Submit question to affygility@gmail.com
5.  iPhone voice memos, record
6.  Leave a message on our listener voicemail feedback line at 206-984-3214.
Next after the overview of the topics, we will jump into discussing each of them.  Depending on the depth of the discussion we may only get to discuss one or two of them.  Topics that could be discussed include all kinds of things, including potent compound safety, occupational toxicology, industrial hygiene, containment validation, managing regulatory requirements, compliance management software, and environmental issues.  We may also get into career development for environmental, health and safety professionals We also would like to see about getting an online interview or two going.  If anyone has something important to discuss, send me an email and I can arrange something.
Finally, in each episode, I will wrap the podcast up by discussing any upcoming events that you may want to watch out for.
Alright.
So, let’s get onto our next topic is “who is this podcast intended for.”
This podcast is intended for practicing environmental, health and safety professionals in the BioPharma industry.  The audience that this is really for the EH&S professional that is dealing with these issues on a day-to-day basis.  The person that is in the trenches getting it done. We really want those people to be involved. While we may discuss some strategic and theoretical issues, we really want to have those hands-on folks to participate.  We really encourage you to submit questions.  I should mention that when I’m talking about the BioPharma industry I actually mean biotechnology, pharmaceutical, medical device, and related industries.
Now with all the administrative overview stuff out of the way, let’s talk about the unique challenges that are presented to EH&S professional in the Biopharma industry.
First off it’s a heavily regulated industry. Besides the regulatory demands of the drug approval agencies, Biopharma companies have to deal with occupational health, biosafety, chemical exposure, hazardous wastes, radiation safety, hazardous materials transportation safety, and many other regulatory requirements.  For smaller BioPharma companies, these complex requirements may fall upon the shoulders of maybe just one person.  Just yesterday, I was working with a client that not only has EH&S responsibilities, but also has laboratory support, purchasing, and facility support. Yes, they’re a small startup company, but the regulatory requirements are still there.
The second challenge is, that you may be dealing with highly potent novel compounds.  These compounds may be very early in the discovery phase with little or no toxicology or hazard information. However, you’re still expected to provide the necessary controls and training to protect your employees from adverse health effects.
Finally, the pace and pressures of the BioPharma industry can be intense. As an EH&S professional in this industry, you have to understand that you need to do whatever you can so that you don’t delay the drug development time-line.  Do that once and it will be a short career at your current company.
Alright now, let’s move on to the next topic – surviving a regulatory inspection.
1. Preparation begins well before an inspection
a. Records in order
b. Train your employees
2. Be nice.
3. Determine why they are there.
4. Don’t give the dog and pony show
5. Don’t answer a question that wasn’t asked
6. Silence is golden
7. Provide only the records that are requested. Copy those provided.
8. Provide quick follow up
9.  Learn from the event
Well that does it for this week’s podcast, But before we go  One brief announcement, for those of you in the San Francisco Bay Area, Affygility Solutions will be hosting Affygility Solution’s Unplugged at the Club Bistro inside the Crowne Plaza in Foster City on December 14th from 5-7 p.m.  Stop on by and say hi.  I would love to meet you.  I’ll be wearing a grey shirt with a Affygility Solutions logo over the pocket.  [play exit music]
That does it for now, in next week’s episode, I will be discussing at what point of drug development that should you start categorizing a potent compound.  Again, please email your questions to affygility@gmail.com or call our listener voicemail feedback line at: 206-984-3214
Direct download: BioPharma_EHS_Podcast_Episode_No._1.mp3
Category:general -- posted at: 11:58am MST