Biopharma EHS
By Affygility Solutions, LLC
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Podcast Description
BioPharma EH&S Podcast. The latest discussion on potent compound safety, occupational toxicology, industrial hygiene, and compliance management software. To submit questions or comments to the podcast email affygility@gmail.com or call our listener voicemail line at 206-984-3214.
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CleanBioPharma EHS Podcast Episode No. 18 | 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. <span s | 1/31/12 | Free | View In iTunes |
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CleanBiopharma EHS Podcast Episode No. 17 | 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: Affygility Solutions' webinars. These webinars include: Advance Topics in Potent Compound Safety Dermal Exposure and Absorption of Active Pharmaceutical Ingredients Isoflurane Safety Society of Toxicology Annual Meeting in San Francisco, CA Society of Chemical Hazard Communication Spring Meeting in Nashville, TN The above webinars are a gr | 12/23/11 | Free | View In iTunes |
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CleanBiopharma EHS Podcast Episode No. 16 | 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. | 5/14/11 | Free | View In iTunes |
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CleanBiopharma EHS Podcast Episode No. 15 | 0 0 1 884 5041 Affygility Solutions 42 11 5914 14.0 Normal 0 false false false EN-US JA X-NONE <w:LsdException Locked="false" Priority="1 | 4/21/11 | Free | View In iTunes |
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CleanBioPharma EHS Podcast Episode #14 | 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. | 4/2/11 | Free | View In iTunes |
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CleanBioPharma EHS Podcast #13 | 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? <span style="font-family: Symbol; mso-fareast-font-family: Symbol; | 3/27/11 | Free | View In iTunes |
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CleanBiopharma EHS Podcast Episode #12 | 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 i | 3/5/11 | Free | View In iTunes |
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CleanThe Evolution of Environmental, Health and Safety Compliance and Operational Risk Management Software | 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 mana | 2/26/11 | Free | View In iTunes |
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CleanBiopharma EHS Podcast Episode #10.mp3 | 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, alwa | 2/23/11 | Free | View In iTunes |
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CleanBiopharma EHS Podcast Episode #9 | 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. <p style="font-family: Georg | 2/12/11 | Free | View In iTunes |
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CleanBiopharma EHS Podcast Episode #8 | 0 0 1 1630 9291 Affygility Solutions 77 21 10900 14.0 Normal 0 false false false EN-US JA X-NONE <w:LsdExcepti | 2/1/11 | Free | View In iTunes |
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CleanBiopharma EHS Podcast - Episode No. 7 | 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 | 1/25/11 | Free | View In iTunes |
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CleanBioPharma EHS Podcast Episode #6 | 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. | 1/9/11 | Free | View In iTunes |
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CleanBioPharma EHS Podcast Episode #5 | 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. | 1/2/11 | Free | View In iTunes |
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CleanBioPharma EHS Podcast Episode #4 | 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. | 12/22/10 | Free | View In iTunes |
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CleanBioPharma EHS Podcast, Episode #3, December 19th, 2010 | 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. | 12/18/10 | Free | View In iTunes |
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CleanBioPharma EHS Podcast - Episode #2, December 12, 2010 | 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. | 12/12/10 | Free | View In iTunes |
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CleanBiopharma EHS Podcast - Episode #1, December 6th, 2010. Introduction to the podcast, surviving a regulatory inspection | 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: * potent compound safety * occupational toxicology * compliance management software. 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 p | 12/6/10 | Free | View In iTunes |
| Total: 18 Episodes |
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