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Biopharma EHS

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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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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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Biopharma EHS

Latest release on Feb 03, 2020

All 27 episodes from oldest to newest

Biopharma EH&S podcast episode #27

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

Well, it’s 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&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&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&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

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Feb 03 2020

34mins

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Biopharma EHS Podcast Episode 26

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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&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&S professionals.

Need nutrition coaching? Contact Anniebethfit.com

Jan 03 2020

27mins

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BioPharma EHS Podcast Episode 25

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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.

May 06 2017

30mins

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Biopharma EHS Podcast Episode #24

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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.

Jan 17 2016

27mins

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Biopharma EHS Podcast Episode #23

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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

Nov 19 2014

18mins

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

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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.

Oct 24 2014

24mins

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Biopharma EHS Podcast Episode No. 20

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BioPharma EH&S Podcast Episode No. 20

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

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

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

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

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

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

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

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

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

- Measure usage;

- Ensure data quality;

- Engage users during meetings;

- Tie individual compensation to usage; and

- Use peer pressure.

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

- Ensure executive leadership involvement;

- Identify and reward super users;

- Perform floor-walking;

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

- Mandate both timeliness and data quality.

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

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

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

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

Have a great rest of the day.

Jul 14 2013

9mins

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

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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.

Jun 09 2013

30mins

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

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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.

Jul 01 2012

35mins

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BioPharma EHS Podcast Episode No. 18

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

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

Overview

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

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

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

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

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

[audio portion]

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

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

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

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

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

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

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

 Have a great rest of the day.

Jan 31 2012

28mins

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