BioPharma EH&amp;S Podcast Episode No. 28. Hello everybody and welcome back to another Episode of the BioPharma EH&amp;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 Monday, June 14th, 2021 and I’m excited to be back today recording today. We have full show for today and a lot of great things to talk about, so let’s go ahead and get started. As always I like to mention 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 27 Then I will cover our main topic for today, which is titled, “Top mistakes and tricks used by cheap providers of PDE reports.” So, let’s go ahead get started.  Last time in Episode 27 we discussed the topic of “coronavirus and precautions that should be taken by business travelers.” That was recorded back on Feb 3rd, 2020. Who would have thought at that time that this would have become such a huge global crisis. We are going to be short on time today, so I would suggest if that topic interest you that you go back to episode and listen to the entire episode. Alright, so let's now move into our main topic for today, which is titled the “Top mistakes and tricks used by cheap providers of PDE monographs.” The talk is about 15-20 minutes long, so let’s go ahead and get started. At Affygility Solutions we see dozens, if not hundreds, of PDE reports each year from different providers. Some of the PDE reports are excellent and others have a lot of room for improvement. Often, when reviewing reports from cheap providers, we see many technical errors and tactics to fool you into thinking that you’re getting quality reports. These technical errors and tactics include:  Relying too heavily on animal data for the selection of the point of departure (otherwise known as the PoD) and ignoring currently available human clinical data. Well, if you carefully read the EMA guidance document, on page 6 of the document, in section 4.2 it states,  “If the most critical effect identified to determine a health-based exposure limit is based on pharmacological and/or toxicological effects observed in humans rather than animals, the use of the PDE formula may be inappropriate and a substance-specific assessment of the clinical data may be used for this purpose.” This is important. Often, we see cheap providers get in a rush to find a NOAEL value to use as the point of departure, which, as you may know, is typically from an animal model. Then in the process, cheap providers may ignore the human clinical data which may show adverse effects as the minimum effective dose. This is a mistake. Selection of the appropriate point of departure requires a thorough analysis of all the possible points of departure by an expert toxicologist, then selection of the PoD that results in the most restrictive PDE that is relevant to humans. This takes time.  Over aggressive use of F factors and adjustment factors. Often this is due to lack of experience of the toxicologist and that they are not confident in their abilities. It should be mention that if you start seeing a composite F factor mathematical product approaching 10,000 or more; it means you really don’t know much about your molecule or that there is so much missing data that the F-factor method is not appropriate. When you see the happening you should carefully examine how they justified their factors. Performing a limited search strategy or not acquiring important primary sources of information or using old data. Often, a good way to discover to see if the search strategy was too limited is to look at the number and quality of the references. If they only have 4 or 5 molecule-specific references and all of those are from “free sources” they likely didn’t do a good search job other than looking for free data. High quality data sources, such as proprietary scientific databases and journal articles cost money. Cheap providers don’t have that kind of budget, so they ignore it. Also, how current is the data? If data is over 6 years old or more, it’s probably outdated, and more current studies may be available. Ignoring conflicting or missing data. This typically occurs in the evaluation of genotoxicity data; where you’ll have mixed results (some positive and some negative). Did the author of the PDE report do a good job of analyzing this conflicting data or did they ignore it? How did they address missing data such as missing reproductive and developmental studies? Creating a different monograph for each salt form of the molecule; thus, requiring you to buy separate monographs. A large majority of all drug molecules used in medicinal therapy are administered as salts. Often, a drug substance has certain suboptimal properties that can be overcome by pairing a basic or acidic drug molecule with a counterion to create a salt version of the drug. Creating a salt version of the drug can improve solubility, stability, taste, manufacturability, and other key properties. In all but a few rare cases, the toxicology of the basic or acidic drug and the salt form are the same. Here at Affygility Solutions, when we are reviewing the scientific literature for a drug compound, the expert toxicologists are mindful of any differences. Making statements that are not scientifically supported. Every source of scientific data must be cited. And you should be able to trace it down. It doesn’t have to be word-for-word, as long as the meaning is the same. Relying on data from safety data sheets (SDS) of questionable credibility. The information on safety data sheets may be mentioned in a PDE report, but it should never be used as the primary source of data. This is because the backup studies are generally not available. I should mentioned that the credibility of the content of safety data sheets varies widely, from those that are outright false to those that are quite good. Attempting to disguise a PDE report as a comprehensive document by non-value filler materials. Filler material can includes a report cover, a lengthy, but unnecessary table of contents, a glossary, lengthy tables of irrelevant data, and CVs in every PDE report. In addition, some providers use large header and footer margins with industry association, corporate logos and addresses on every page to make a longer document. These items provide zero value and are there to just give the false impression that it’s a lengthy and comprehensive report. I should mention that about a month ago I was speaking at a virtual conference and one of the other presenters indicated that a PDE monograph really only needs to be 15 or 16 pages long, as long as the data is well summarized. Not openly disclosing that their reports expire in 3-5 years; thus, requiring that you purchase a new report upon expiration. Typically,  this is buried somewhere in the document or in the terms and conditions. So, it may be a cheap initial cost, but you’re going to have to continue to buy replacement reports for many years to come. Not a good tactic. Not using qualified or certified toxicologists to prepare and review the reports. This is a big one. Qualified toxicologists don’t work for low wages. And if a person is certified, either a DABT or ERT-registered toxicologist the salary is up there. Cheap providers can’t support those kind of salaries.  O.k.  That does it for this week’s show. 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. 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.

BioPharma EH&amp;S Podcast Episode No. 28. Hello everybody and welcome back to another Episode of the BioPharma EH&amp;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 Monday, June 14th, 2021 and I’m excited to be back today recording today. We have full show for today and a lot of great things to talk about, so let’s go ahead and get started. As always I like to mention 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 27 Then I will cover our main topic for today, which is titled, “Top mistakes and tricks used by cheap providers of PDE reports.” So, let’s go ahead get started.  Last time in Episode 27 we discussed the topic of “coronavirus and precautions that should be taken by business travelers.” That was recorded back on Feb 3rd, 2020. Who would have thought at that time that this would have become such a huge global crisis. We are going to be short on time today, so I would suggest if that topic interest you that you go back to episode and listen to the entire episode. Alright, so let's now move into our main topic for today, which is titled the “Top mistakes and tricks used by cheap providers of PDE monographs.” The talk is about 15-20 minutes long, so let’s go ahead and get started. At Affygility Solutions we see dozens, if not hundreds, of PDE reports each year from different providers. Some of the <a href="https://affygility.com/services/pde-reports-by-pharma-industry-experts.html" rel="noopener nofollow" target="_blank">PDE reports</a> are excellent and others have a lot of room for improvement. Often, when reviewing reports from cheap providers, we see many technical errors and tactics to fool you into thinking that you’re getting quality reports. These technical errors and tactics include: <ol> <li>Relying too heavily on animal data for the selection of the point of departure (otherwise known as the PoD) and ignoring currently available human clinical data. Well, if you carefully read the EMA guidance document, on page 6 of the document, in section 4.2 it states,</li> </ol> “If the most critical effect identified to determine a health-based exposure limit is based on pharmacological and/or toxicological effects observed in humans rather than animals, the use of the PDE formula may be inappropriate and a substance-specific assessment of the clinical data may be used for this purpose.” This is important. Often, we see cheap providers get in a rush to find a NOAEL value to use as the point of departure, which, as you may know, is typically from an animal model. Then in the process, cheap providers may ignore the human clinical data which may show adverse effects as the minimum effective dose. This is a mistake. Selection of the appropriate point of departure requires a thorough analysis of all the possible points of departure by an expert toxicologist, then selection of the PoD that results in the most restrictive PDE that is relevant to humans. This takes time. <ol> <li>Over aggressive use of F factors and adjustment factors. Often this is due to lack of experience of the toxicologist and that they are not confident in their abilities. It should be mention that if you start seeing a composite F factor mathematical product approaching 10,000 or more; it means you really don’t know much about your molecule or that there is so much missing data that the F-factor method is not appropriate. When you see the happening you should carefully examine how they justified their factors.</li> <li>Performing a limited search strategy or not acquiring important primary sources of information or using old data. Often, a good way to discover to see if the search strategy was too limited is to look at the number and quality of the references. If they only have 4 or 5 molecule-specific references and all of those are from “free sources” they likely didn’t do a good search job other than looking for free data. High quality data sources, such as proprietary scientific databases and journal articles cost money. Cheap providers don’t have that kind of budget, so they ignore it. Also, how current is the data? If data is over 6 years old or more, it’s probably outdated, and more current studies may be available.</li> <li>Ignoring conflicting or missing data. This typically occurs in the evaluation of genotoxicity data; where you’ll have mixed results (some positive and some negative). Did the author of the PDE report do a good job of analyzing this conflicting data or did they ignore it? How did they address missing data such as missing reproductive and developmental studies?</li> <li>Creating a different monograph for each salt form of the molecule; thus, requiring you to buy separate monographs. A large majority of all drug molecules used in medicinal therapy are administered as salts. Often, a drug substance has certain suboptimal properties that can be overcome by pairing a basic or acidic drug molecule with a counterion to create a salt version of the drug. Creating a salt version of the drug can improve solubility, stability, taste, manufacturability, and other key properties. In all but a few rare cases, the toxicology of the basic or acidic drug and the salt form are the same. Here at Affygility Solutions, when we are reviewing the scientific literature for a drug compound, the expert toxicologists are mindful of any differences.</li> <li>Making statements that are not scientifically supported. Every source of scientific data must be cited. And you should be able to trace it down. It doesn’t have to be word-for-word, as long as the meaning is the same.</li> <li>Relying on data from safety data sheets (SDS) of questionable credibility. The information on safety data sheets may be mentioned in a PDE report, but it should never be used as the primary source of data. This is because the backup studies are generally not available. I should mentioned that the credibility of the content of safety data sheets varies widely, from those that are outright false to those that are quite good.</li> <li>Attempting to disguise a PDE report as a comprehensive document by non-value filler materials. Filler material can includes a report cover, a lengthy, but unnecessary table of contents, a glossary, lengthy tables of irrelevant data, and CVs in every PDE report. In addition, some providers use large header and footer margins with industry association, corporate logos and addresses on every page to make a longer document. These items provide zero value and are there to just give the false impression that it’s a lengthy and comprehensive report. I should mention that about a month ago I was speaking at a virtual conference and one of the other presenters indicated that a PDE monograph really only needs to be 15 or 16 pages long, as long as the data is well summarized.</li> <li>Not openly disclosing that their reports expire in 3-5 years; thus, requiring that you purchase a new report upon expiration. Typically,  this is buried somewhere in the document or in the terms and conditions. So, it may be a cheap initial cost, but you’re going to have to continue to buy replacement reports for many years to come. Not a good tactic.</li> <li>Not using qualified or certified toxicologists to prepare and review the reports. This is a big one. Qualified toxicologists don’t work for low wages. And if a person is certified, either a <a href="Top%20mistakes%20and%20tricks%20used%20by%20cheap%20providers%20of%20PDE%20reports." rel="noopener nofollow" target="_blank">DABT</a> or ERT-registered toxicologist the salary is up there. Cheap providers can’t support those kind of salaries.</li> </ol> O.k.  That does it for this week’s show. You can also stalk us on twitter at <a href="http://twitter.com/Affygility" rel="nofollow" target="_blank">twitter.com/Affygility</a>, on Facebook by searching for Affygility Solutions and giving us a “Like”, and finally on LinkedIn by searching for <a href="https://www.linkedin.com/company/246416/admin/" rel="nofollow" target="_blank">Affygility Solutions</a>. 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.

Biopharma EHS Podcast Episode 28 - PDE reports

Hello everybody and welcome back to another Episode of the BioPharma EH&amp;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 Wednesday, January 29th, 2020, and I’m excited to be back today recording today. We have full show for today and a lot of great things to talk about, so let’s go ahead and get started. As always I like to mention 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 26 and then we will cover our main topic for today – which is an interview with Mark Cunningham-Hill where we will discuss the coronavirus and precautions that business travelers should take and other precautions in general when traveling on business internationally. Then finally, after the interview, we will discuss events and happenings of interest to the EH&amp;S professional’s in the biopharma industry. In our last episode, episode 26, we had an interview with Dave Eherts. Dave is the Vice President of Global EH&amp;S for Allergan, and back in October, 2019 Dave was honored by the National Association for Environmental Management with NAEM’s Lifetime Achievement Award. It was a great interview and lasted about 25 minutes, so if that is something that interests you I suggest you go back to episode 26 and listen to the whole interview. Alright, so without further delay, let’s get started with our main interview. With me on the line is Dr. Mark Cunningham-Hill, President of Worldwide Health Consulting, LLC. Mark has 30 years of global experience leading large multinational’s responses to pandemics such as avian flu, SARS, MERS and Zika.  The last time we had Mark on the podcast was back in May of 2017, so I will let Mark add some additional details. Dean  We have heard a lot on the news recently about this new coronavirus from Wuhan, China. From what you know, what is the latest situation?  Mark:  I will run through key facts # cases, deaths, countries – p2p spread etc Key actions taken by China, other countries and businesses so far Warning about false stories on social media … it IS NOT a deliberate plot by the pharmaceutical companies to sell more vaccines!   Dean:  I gather MERS (Middle East Respiratory Syndrome) , SARS (Severe Acute Respiratory Syndrome) and this new virus are all coronaviruses – how similar are they?  Mark:  I will cover similarities, differences and inferences we can make from the previous SARS and MERS Source of disease  - bats, camels and wild food markets…  Dean:  I have seen reference to the R0 number for this new virus what does it mean  Mark  The R naught is the basic reproduction number ……….. give explanation and range for SARS and measles  Dean:  How is the virus spread and how can you protect yourself from getting the disease?  Mark:  …………witchcraft 😊 ……… ? a symptomless transmission Talk through prevention  Dean:  Are there any vaccines or antivirals that work?  Mark  Talk about no vaccines but with genetic code (for test) and virus isolated work starting on developing a vaccine … but ………………  Dean:  Coronavirus and precautions business travelers should take?  Mark:  Talk about following company CDC travel guidance Hand washing Avoiding sick people etc…. ………… Letting people know where you are … Dean you are off to Nepal in March and you came across a great resource – do you want to tell the listeners about this resource  Dean:  STEP Program Mark what other resources are out there?  Mark  CDC and other travel websites Corporate travel companies such as ISOS and Travax Dr Google …. With caveats!  Dean:  What do you think will happen over the next few weeks or months  Mark  I will give a balanced answer and refrain from a doomsday answer 😊   Dean  How about more in general, what precautions and preparations should business travelers be taking when traveling outside the country? (health insurance, vaccinations, registering with the STEP program, etc.)  Alright, so that does it for the interview, let’s now move onto events and happenings that are of interest to EH&amp;S professionals in the biopharma industry. First, on February 19-21st in Prague, Czech Republic there’s the 2nd Annual Highly Potent APIs Summit. Affygility Solutions is a sponsor at this event and also will be presenting. If you happen to be attending, please stop me and say hello. Next, on March 15-18th, there is the Society of Toxicology Annual meeting in Anaheim, California. Dr. James Damewood, Sr. Director of Occupational Toxicology for Affygility Solutions will be attending this event. And, finally, on May 5th through 7th, CPhI North America will be held in Philadelphia, Pennsylvania. Numerous employees of Affygility Solutions will be attending this event. 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 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 Links  Coronavirus 2019-nCoV Tracker John Hopkins University Smart Traveler Enrollment Program - STEP. U.S. Department of State   Looking for nutritional coaching go to Annie Beth Fitness

Hello everybody and welcome back to another Episode of the BioPharma EH&amp;S Podcast, my name is Dean Calhoun of <a href="https://affygility.com" rel="noopener nofollow" target="_blank">Affygility Solutions</a> 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 Wednesday, January 29th, 2020, and I’m excited to be back today recording today. We have full show for today and a lot of great things to talk about, so let’s go ahead and get started. As always I like to mention 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 26 and then we will cover our main topic for today – which is an interview with Mark Cunningham-Hill where we will discuss the coronavirus and precautions that business travelers should take and other precautions in general when traveling on business internationally. Then finally, after the interview, we will discuss events and happenings of interest to the EH&amp;S professional’s in the biopharma industry. In our last episode, episode 26, we had an interview with Dave Eherts. Dave is the Vice President of Global EH&amp;S for Allergan, and back in October, 2019 Dave was honored by the <a href="https://www.naem.org/" rel="noopener nofollow" target="_blank">National Association for Environmental Management</a> with NAEM’s Lifetime Achievement Award. It was a great interview and lasted about 25 minutes, so if that is something that interests you I suggest you go back to episode 26 and listen to the whole interview. Alright, so without further delay, let’s get started with our main interview. With me on the line is Dr. Mark Cunningham-Hill, President of <a href="https://www.worldwidehealthconsulting.com/" rel="noopener nofollow" target="_blank">Worldwide Health Consulting, LLC</a>. Mark has 30 years of global experience leading large multinational’s responses to pandemics such as avian flu, SARS, MERS and Zika.  The last time we had Mark on the podcast was back in May of 2017, so I will let Mark add some additional details. Dean <ul> <li>We have heard a lot on the news recently about this new coronavirus from Wuhan, China. From what you know, what is the latest situation?</li> </ul> Mark: <ul> <li>I will run through key facts # cases, deaths, countries – p2p spread etc</li> <li>Key actions taken by China, other countries and businesses so far</li> <li>Warning about false stories on social media … it IS NOT a deliberate plot by the pharmaceutical companies to sell more vaccines!</li> </ul>  Dean: <ul> <li>I gather MERS (Middle East Respiratory Syndrome) , SARS (Severe Acute Respiratory Syndrome) and this new virus are all coronaviruses – how similar are they?</li> </ul> Mark: <ul> <li>I will cover similarities, differences and inferences we can make from the previous SARS and MERS</li> <li>Source of disease  - bats, camels and wild food markets…</li> </ul> Dean: <ul> <li>I have seen reference to the R0 number for this new virus what does it mean</li> </ul> Mark <ul> <li>The R naught is the basic reproduction number ……….. give explanation and range for SARS and measles</li> </ul> Dean: <ul> <li>How is the virus spread and how can you protect yourself from getting the disease?</li> </ul> Mark: <ul> <li>…………witchcraft 😊</li> <li>……… ? a symptomless transmission</li> <li>Talk through prevention</li> </ul> Dean: <ul> <li>Are there any vaccines or antivirals that work?</li> </ul> Mark <ul> <li>Talk about no vaccines but with genetic code (for test) and virus isolated work starting on developing a vaccine … but ………………</li> </ul> Dean: <ul> <li>Coronavirus and precautions business travelers should take?</li> </ul> Mark: <ul> <li>Talk about following company CDC travel guidance</li> <li>Hand washing</li> <li>Avoiding sick people etc….</li> <li>…………</li> <li>Letting people know where you are … Dean you are off to Nepal in March and you came across a great resource – do you want to tell the listeners about this resource</li> </ul> Dean: <ul> <li>STEP Program</li> <li>Mark what other resources are out there?</li> </ul> Mark <ul> <li>CDC and other travel websites</li> <li>Corporate travel companies such as ISOS and Travax</li> <li>Dr Google …. With caveats!</li> </ul> Dean: <ul> <li>What do you think will happen over the next few weeks or months</li> </ul> Mark <ul> <li>I will give a balanced answer and refrain from a doomsday answer 😊</li> </ul>  Dean  How about more in general, what precautions and preparations should business travelers be taking when traveling outside the country? (health insurance, vaccinations, registering with the STEP program, etc.)  Alright, so that does it for the interview, let’s now move onto events and happenings that are of interest to EH&amp;S professionals in the biopharma industry. First, on February 19-21st in Prague, Czech Republic there’s the <a href="https://qepler.com/events/highly-potent-apis-summit-2020.html" rel="nofollow" target="_blank">2nd Annual Highly Potent APIs Summit</a>. Affygility Solutions is a sponsor at this event and also will be presenting. If you happen to be attending, please stop me and say hello. Next, on March 15-18th, there is the <a href="https://www.toxicology.org/events/am/AM2020/index.asp" rel="nofollow" target="_blank">Society of Toxicology Annual meeting</a> in Anaheim, California. Dr. James Damewood, Sr. Director of Occupational Toxicology for Affygility Solutions will be attending this event. And, finally, on May 5th through 7th, CPhI North America will be held in Philadelphia, Pennsylvania. Numerous employees of Affygility Solutions will be attending this event. O.k.  That does it for this week’s show.  Remember to submit your questions to our podcast email at podcast at <a href="http://Affygility.com" rel="nofollow" target="_blank">Affygility.com</a>.  You can also follow us on twitter at <a href="http://twitter.com/Affygility" rel="nofollow" target="_blank">twitter.com/Affygility</a>, 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 Links <a href="https://gisanddata.maps.arcgis.com/apps/opsdashboard/index.html#/bda7594740fd40299423467b48e9ecf6?utm_source=morning_brew" rel="nofollow" target="_blank"> Coronavirus 2019-nCoV Tracker John Hopkins University</a> <a href="https://step.state.gov/step/" rel="noopener nofollow" target="_blank">Smart Traveler Enrollment Program - STEP. U.S. Department of State</a> Looking for <a href="https://anniebethfit.com/" rel="noopener nofollow" target="_blank">nutritional coaching</a> go to Annie Beth Fitness

Biopharma EH&S podcast episode #27

Welcome back to the Biopharma EHS podcast. In this episode, Dean Calhoun of Affygility Solutions interviews Dave Eherts, Vice President of Global EHS for Allergan. In this 25 minute interview we discuss a wide variety of EH&amp;S issues that Dave was involved in over his 30+ years in EHS. These issues include managing the financial aspects of EHS, potent compound safety and the challenges with occupational exposure limits for pharmaceuticals, and other career advice for EH&amp;S professionals. Need nutrition coaching? Contact Anniebethfit.com

Welcome back to the Biopharma EHS podcast. In this episode, Dean Calhoun of <a href="https://affygility.com/oel/catalog.html" rel="nofollow" target="_blank">Affygility Solutions</a> interviews Dave Eherts, Vice President of Global EHS for Allergan. In this 25 minute interview we discuss a wide variety of EH&amp;S issues that Dave was involved in over his 30+ years in EHS. These issues include managing the financial aspects of EHS, <a href="https://affygility.com/oel/catalog.html" rel="nofollow" target="_blank">potent compound safety</a> and the challenges with occupational exposure limits for pharmaceuticals, and other career advice for EH&amp;S professionals. Need <a href="https://anniebethfit.com/" rel="noopener nofollow" target="_blank">nutrition coaching</a>? Contact <a href="http://Anniebethfit.com" rel="nofollow" target="_blank">Anniebethfit.com</a>

Biopharma EHS Podcast Episode 26

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.

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 <a href="https://goo.gl/M4rqZX" rel="nofollow" target="_blank">Affygility Solutions</a> 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 <a href="https://goo.gl/EEoG52" rel="nofollow" target="_blank">occupational toxicology</a>, dermal exposures to such compounds as <a href="https://goo.gl/3Ll7Wi" rel="nofollow" target="_blank">fentanyl</a> or <a href="https://goo.gl/PywWyN" rel="nofollow" target="_blank">nicotine</a>, 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.

BioPharma EHS Podcast Episode 25

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.

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.

Biopharma EHS Podcast Episode #24

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

In this episode of the Biopharma EHS podcast, Dean M. Calhoun, CIH, President and CEO of Affygility Solutions interviews Kevin Rosenthal of <a href="http://www.pharmatek.com/?scr=affygilitylibsyn" rel="nofollow" target="_blank">Pharmatek Laboratories</a>. During the interview we discuss handling potent compounds, <a href="http://affygility.com/services/potent-compound-safety-program.html?scr=libsynblog" rel="nofollow" target="_blank">potent compound safety</a>, 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 <a href="http://affygility.com?scr=libsyn" rel="nofollow" target="_blank">affygility.com</a>

Biopharma EHS Podcast Episode #23

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.

In this episode of the Biopharma EHS Podcast, Dean M. Calhoun, CIH, President and CEO of <a href="http://affygility.com/?scr=libsyn" rel="nofollow" target="_blank">Affygility Solutions</a>, interviews Ms. Stephanie Wilkins, President of <a href="http://www.pharmaconsultus.com/?scr=libsyn" rel="nofollow" target="_blank">PharmaConsult US</a>, 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 <a href="http://affygility.com/oel/catalog.html?scr=libsyn" rel="nofollow" target="_blank">OEL Fastrac monographs</a>. We have many OEL monographs that come with ADEs.

Risk-MaPP, ADEs, and PDEs: Their importance to multi-product pharmaceutical manufacturing facilities

BioPharma EH&amp;S Podcast Episode No. 20 Hello everybody and welcome back to another Episode of the BioPharma EH&amp;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&amp;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.

BioPharma EH&amp;S Podcast Episode No. 20 Hello everybody and welcome back to another Episode of the BioPharma EH&amp;S Podcast, my name is Dean Calhoun of <a href="http://affygility.com/" rel="nofollow" target="_blank">Affygility Solutions</a> and this is the podcast dedicated to discussing critical environmental, health and safety issues facing the biopharma industry, helping you take your <a href="http://affygility.com/" rel="nofollow" target="_blank">environmental, health and safety programs</a> 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 <a href="http://affygility.com/affytrac/" rel="nofollow" target="_blank">EH&amp;S Software</a> – 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 <a href="http://affygility.com/affytrac/" rel="nofollow" target="_blank">EHS software</a> – the challenge of user adoption. So without further delay, here we go.  A little over a year ago, I created a post on <a href="http://affygility.com/affytrac/" rel="nofollow" target="_blank">EHS Compliance Management Software</a> - 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 <a href="http://oelfastrac.com" rel="nofollow" target="_blank">oelfastrac.com</a>, which is a convenient and affordable way to obtain high-quality <a href="http://affygility.com/oel/" rel="nofollow" target="_blank">occupational exposure limit monographs for common APIs</a>. To learn more, please go to <a href="http://oelfastrac.com" rel="nofollow" target="_blank">oelfastrac.com</a>.  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 <a href="https://twitter.com/affygility" rel="nofollow" target="_blank">twitter.com/Affygility</a>, on Facebook at <a href="https://www.facebook.com/AffygilitySolutions?fref=ts" rel="nofollow" target="_blank">facebook.com/affygilitysolutions</a> 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.

Biopharma EHS Podcast Episode No. 20

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.

In this podcast, Dean M. Calhoun of <a href="http://affygility.com/" rel="nofollow" target="_blank">Affygility Solutions</a> 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.

Biopharma EHS Podcast - Episode No. 20: The Future of the Pharmaceutical Industry - The next 100 years.

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.

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 <a href="http://affygility.com/services/potent-compound-safety-categorization.html" rel="nofollow" target="_blank">potent compound safety</a>, EHS auditing, occupational toxicology or industrial hygiene, please <a href="http://affygility.com/contact/" rel="nofollow" target="_blank">contact Affygility Solutions</a>.

Environmental, health and safety auditing of pharmaceutical facilities handling highly potent compounds

BioPharma EH&amp;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.

Biopharma EHS

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&amp;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.

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&amp;S Podcast, my name is Dean Calhoun of <a href="http://affygility.com/" rel="nofollow" target="_blank">Affygility Solutions</a> 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 <a href="http://www.osobio.com/" rel="nofollow" target="_blank">OSO Biopharmaceuticals</a>.  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 “<a href="http://affygility.com/services/containment.html" rel="nofollow" target="_blank">Containment Validation and Surrogate Monitoring</a>.”  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 <a href="http://Affygility.com" rel="nofollow" target="_blank">Affygility.com</a>.  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 <a href="http://affygility.com/training/manufacturing-highly-potent-compounds-apis-drugs.html" rel="nofollow" target="_blank">Manufacturing Highly Potent Compounds – Understanding and Controlling the Risks</a>.  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 <a href="http://affygility.com/training/isoflurane.html" rel="nofollow" target="_blank">isoflurane safety</a> webinar.  Again, if any of that interests you, I would suggest that you go to <a href="http://Affygility.com" rel="nofollow" target="_blank">Affygility.com</a> 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 <a href="http://sot.org" rel="nofollow" target="_blank">sot.org</a>  Then at the end of March, the <a href="http://www.schc.org/" rel="nofollow" target="_blank">Society of Chemical Hazard Communication</a> 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 <a href="http://Affygility.com" rel="nofollow" target="_blank">Affygility.com</a>.  You can also follow us on twitter at <a href="http://twitter.com/Affygility" rel="nofollow" target="_blank">twitter.com/Affygility</a>, on Facebook at <a href="http://facebook.com/affygilitysolutions" rel="nofollow" target="_blank">facebook.com/affygilitysolutions</a> 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 <a href="http://affygility.com/affytrac/" rel="nofollow" target="_blank">environmental, health and safety software</a> and services to the pharmaceutical, biotechnology, and medical device industry.   Have a great rest of the day.

BioPharma EHS Podcast Episode No. 18

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.  Often call SMEPAC testing. 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 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

Containment Validation and Surrogate Monitoring In this episode of the Biopharma EHS podcast, Dean M. Calhoun, CIH, President and CEO of <a href="http://affygility.com/" rel="noopener nofollow" target="_blank">Affygility Solutions</a> discusses the following topics: <ul> <li>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 <a href="http://affygility.com/news/category-4-category-5-potent-compounds.html" rel="noopener nofollow" target="_blank">Category 4 and 5 potent compounds</a>.  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.</li> <li>An interview with <a href="http://www.us.bureauveritas.com/wps/wcm/connect/BV_USNew/local/home/our-services/health_safety_environmental/laboratories/about_our_laboratories/key_personnel/lab_key_personnel_lake_zurich" rel="noopener nofollow" target="_blank">Matt Meiners</a>, Division Manager, Laboratory Services for the Bureau Veritas, Lake Zurich, Industrial Hygiene Laboratory.  In this interview, Dean and Matt discuss <a href="http://affygility.com/projects/containment.html" rel="noopener nofollow" target="_blank">containment validation and surrogate monitoring</a>.  Often call <a href="https://affygility.com/potent-compound-corner/2022/10/11/what-is-smepac-testing-in-the-pharmaceutical-industry.html" rel="noopener nofollow" target="_blank">SMEPAC</a> testing. Matt provides insight into why containment validation is necessary, the advantages and disadvantages of different surrogate compounds, the sensitivity of their <a href="http://labs.us.bureauveritas.com/pdf/SurrogateAnalysisReducedpricingflyer.pdf" rel="noopener nofollow" target="_blank">industrial hygiene laboratory methods for surrogate compounds</a>, the advantages and disadvantages of the total dust versus the Institute of Occupational Medicine (IOM) method of sampling.</li> <li>Upcoming events and happenings of interest to environmental, health and safety professionals in the biotechnology, pharmaceutical, and medical device industries.  These events include:</li> <ul> <li>Affygility Solutions' webinars.  These webinars include:</li> <ol> <li>Advance Topics in <a href="http://affygility.com/training/potent.html" rel="noopener nofollow" target="_blank">Potent Compound Safety</a></li> <li><a href="http://affygility.com/training/dermal.html" rel="noopener nofollow" target="_blank">Dermal Exposure and Absorption of Active Pharmaceutical Ingredients</a></li> <li><a href="http://affygility.com/training/isoflurane.html" rel="noopener nofollow" target="_blank">Isoflurane Safety</a></li> </ol> <li><a href="http://www.toxicology.org/ai/meet/am2012/submitab.asp" rel="noopener nofollow" target="_blank">Society of Toxicology</a> Annual Meeting in San Francisco, CA</li> <li><a href="http://schc.org/show_news.php?subaction=showfull&amp;id=1300465385&amp;archive=&amp;start_from=&amp;ucat=16&amp;" rel="noopener nofollow" target="_blank">Society of Chemical Hazard Communication Spring Meeting</a> in Nashville, TN</li> </ul> <li>The above webinars are a great way for environmental, health and safety professionals to obtain certification maintenance points.</li> </ul> If you have questions regarding this podcast, please email podcast @ <a href="http://affygility.com" rel="nofollow" target="_blank">affygility.com</a>

Biopharma EHS Podcast Episode No. 17

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.

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: <ul> <li>Review of the last podcast</li> <li>What factors go into determining an active pharmaceutical ingredients as a Category 4 or Category 5 potent compound</li> <li>We provide examples of Category 4 and Category 5 potent compounds</li> <li>Review upcoming events and happenings related to environmental, health and safety in the biotechnology, pharmaceutical, and medical device industry.</li> </ul> If you have any questions please contact Affygility Solutions at 303-884-3028 or visit the <a href="http://affygility.com" rel="nofollow" target="_blank">Affygility Solutions</a> website.

Biopharma EHS Podcast Episode No. 16

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.

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: <a href="http://mashable.com/2009/05/17/twitter-hashtags/" rel="nofollow" target="_blank">http://mashable.com/2009/05/17/twitter-hashtags/</a> 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 <a href="http://affygility.com/services/potent-compound-safety-categorization.html" rel="nofollow" target="_blank">Control Banding</a> – 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 “<a href="http://vimeo.com/21865168" rel="nofollow" target="_blank">Young Guns of Environmental, Health and Safety</a>.”  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 <a href="http://affygility.com/services/toxicology.html" rel="nofollow" target="_blank">occupational exposure limit</a> (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 <a href="http://affygility.com/services/toxicology.html" rel="nofollow" target="_blank">hazard category 4 or 5 compound</a> 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 <a href="http://Affygility.com" rel="nofollow" target="_blank">Affygility.com</a> 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 <a href="http://twitter.com/Affygility" rel="nofollow" target="_blank">twitter.com/Affygility</a>, on Facebook by searching for <a href="http://affygility.com/services/toxicology.html" rel="nofollow" target="_blank">Affygility Solutions</a> 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.

Biopharma EHS Podcast Episode No. 15

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.

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 <a href="http://Affygility.com" rel="nofollow" target="_blank">Affygility.com</a>.  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 <a href="http://Affygility.com" rel="nofollow" target="_blank">Affygility.com</a> 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 <a href="http://twitter.com/Affygility" rel="nofollow" target="_blank">twitter.com/Affygility</a>, 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.

BioPharma EHS Podcast Episode #14

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

In this podcast, Dean Calhoun of Affygility Solutions discusses Social Media and Environmental, Health and SafetyThe twitter hashtag for today’s podcast is <a href="http://twitter.com/#search?q=%23socialehs" rel="nofollow" target="_blank">#socialehs</a>  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 “<a href="http://potentcompoundsafety.com/2011/03/creeping-featurism-environmental-health-safety-software.html" rel="nofollow" target="_blank">Creeping Featurism of Environmental, Health and Safety software</a>."  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 <a href="http://potentcompoundsafety.com/2011/03/emerging-environmental-health-safety.html" rel="nofollow" target="_blank">South by Southwest Interactive</a> 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 <a href="http://www.naem.org/" rel="nofollow" target="_blank">National Association for Environmental Management (NAEM)</a>, 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 <a href="http://twitter.com/Affygility" rel="nofollow" target="_blank">twitter.com/Affygility</a>, 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 <a href="http://Affygility.com" rel="nofollow" target="_blank">Affygility.com</a>.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 <a href="http://Affygility.com" rel="nofollow" target="_blank">Affygility.com</a>.  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 <a href="http://Affygility.com" rel="nofollow" target="_blank">Affygility.com</a> 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 <a href="http://safety.com" rel="nofollow" target="_blank">safety.com</a>. 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 <a href="http://twitter.com/Affygility" rel="nofollow" target="_blank">twitter.com/Affygility</a>, on Facebook by searching for Affygility Solutions and giving us a “Like”, and finally on LinkedIn by searching for Affygility Solutions.

BioPharma EHS Podcast #13

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