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Syndication

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 MDT

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 MDT

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 MDT

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 MDT

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 MDT

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 MDT

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 MDT

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 MDT

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 MDT

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 MDT