Biopharma EHS












February 2011
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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

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 and check out our schedule.

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


BioPharma EH&S Podcast Episode No. 10

Note: This is the abbreviated script of the podcast, for the more detailed version go to

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, 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

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  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 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

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, 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 MDT


Biopharma EHS Podcast Episode #9


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 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 MDT

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Biopharma EHS Podcast Episode #8


Oh yay everybody, that’s right.that’s 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



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, 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 MDT