Biopharma EHS Podcast - Episode #1, December 6th, 2010. Introduction to the podcast, surviving a regulatory inspection

Biopharma EHS

BioPharma EH&S podcast episode 1 December 6th, 2010 Hello everyone welcome to the inaugural episode of BioPharma EH&S podcast, my name is Dean Calhoun and this IS THE podcast where I will discuss environmental, health and safety issues affecting the BioPharma Industry. I’m here to help answer any questions you may have regarding: * potent compound safety * occupational toxicology * compliance management software. I’ll talk more about that later, how you can submit questions to the podcast. Well today, we have a lot to tackle today so let’s get started. One of the first things that I’d like to do, is at the beginning of each podcast is tell you the different topics that I plan on covering in this particular episode. So, the first thing I’d like to cover today is the general format of this podcast, and how YOU can submit questions or feedback to this podcast. Secondly, I’ll cover the type of audience that this podcast is intended for. Then, I’ll cover challenges that environmental, health and safety professionals in the biopharma industry face. How to survive a regulatory inspection And finally we will end the podcast by discussing any upcoming events of interest, and the main topic we will be discussing in the next episode. So let’s get started with the General Format that each episode will follow. 1. ~30 minutes long 2. Start out with brief overview 3. Once a week 4. Submit question to [e-mail] 5. iPhone voice memos, record 6. Leave a message on our listener voicemail feedback line at 206-984-3214. Next after the overview of the topics, we will jump into discussing each of them. Depending on the depth of the discussion we may only get to discuss one or two of them. Topics that could be discussed include all kinds of things, including potent compound safety, occupational toxicology, industrial hygiene, containment validation, managing regulatory requirements, compliance management software, and environmental issues. We may also get into career development for environmental, health and safety professionals We also would like to see about getting an online interview or two going. If anyone has something important to discuss, send me an email and I can arrange something. Finally, in each episode, I will wrap the podcast up by discussing any upcoming events that you may want to watch out for. Alright. So, let’s get onto our next topic is “who is this podcast intended for.” This podcast is intended for practicing environmental, health and safety professionals in the BioPharma industry. The audience that this is really for the EH&S professional that is dealing with these issues on a day-to-day basis. The person that is in the trenches getting it done. We really want those people to be involved. While we may discuss some strategic and theoretical issues, we really want to have those hands-on folks to participate. We really encourage you to submit questions. I should mention that when I’m talking about the BioPharma industry I actually mean biotechnology, pharmaceutical, medical device, and related industries. Now with all the administrative overview stuff out of the way, let’s talk about the unique challenges that are presented to EH&S professional in the Biopharma industry. First off it’s a heavily regulated industry. Besides the regulatory demands of the drug approval agencies, Biopharma companies have to deal with occupational health, biosafety, chemical exposure, hazardous wastes, radiation safety, hazardous materials transportation safety, and many other regulatory requirements. For smaller BioPharma companies, these complex requirements may fall upon the shoulders of maybe just one person. Just yesterday, I was working with a client that not only has EH&S responsibilities, but also has laboratory support, purchasing, and facility support. Yes, they’re a small startup company, but the regulatory requirements are still there. The second challenge is, that you may be dealing with highly potent novel compounds. These compounds may be very early in the discovery phase with little or no toxicology or hazard information. However, you’re still expected to provide the necessary controls and training to protect your employees from adverse health effects. Finally, the pace and pressures of the BioPharma industry can be intense. As an EH&S professional in this industry, you have to understand that you need to do whatever you can so that you don’t delay the drug development time-line. Do that once and it will be a short career at your current company. Alright now, let’s move on to the next topic – surviving a regulatory inspection. 1. Preparation begins well before an inspection a. Records in order b. Train your employees 2. Be nice. 3. Determine why they are there. 4. Don’t give the dog and pony show 5. Don’t answer a question that wasn’t asked 6. Silence is golden 7. Provide only the records that are requested. Copy those provided. 8. Provide quick follow up 9. Learn from the event Well that does it for this week’s podcast, But before we go One brief announcement, for those of you in the San Francisco Bay Area, Affygility Solutions will be hosting Affygility Solution’s Unplugged at the Club Bistro inside the Crowne Plaza in Foster City on December 14th from 5-7 p.m. Stop on by and say hi. I would love to meet you. I’ll be wearing a grey shirt with a Affygility Solutions logo over the pocket. [play exit music] That does it for now, in next week’s episode, I will be discussing at what point of drug development that should you start categorizing a potent compound. Again, please email your questions to [e-mail] or call our listener voicemail feedback line at: 206-984-3214