004 Quality Assurance and Auditing in the Age of Covid-19 - Bettina Kaplan

CMC Live - Chemistry, Manufacturing & Controls

What We Covered

• 02:08 – Bettina Kaplan joins the show to discuss her background in quality assurance, compliance and auditing within the pharmaceutical industry
• 09:43 – Trends in quality auditing that Bettina observed before the shutdown and strategies to ensure a successful audit
• 12:48 – Bettina expounds on when it’s appropriate to have an expert, such as an analyst or a drug substance chemist, present during an audit
• 14:42 – Bettina speaks to challenges that Covid-19 has posed to auditing and how she would prepare for a virtual audit
• 19:48 – Risks and dangers associated with not having regular audits during Covid-19 and the importance of having flexibility as an auditor
• 24:36 – Bettina discusses the evolution and growing acceptance of virtual audits in the pharmaceutical industry, including potential benefits and disadvantages
• 30:05 – Ed, Brian and Meranda thank Bettina for joining the show

Tweetable Quotes

“The person [auditor] needs to be able to communicate properly. So, build a rapport with the auditee. When you build that rapport, auditees tend to tell you more than just your basic questions.”

“So, if you have to cover manufacturing, analytical and all the quality systems in one day to do a thorough audit, there’s no way you can do it with just one person. You need to have the other experts.”

“The other issue is going to an audit. If you’re from a location like where I live, I have to be in quarantine for two weeks before I can even go into an audit. And then I have to be in quarantine for two weeks after. It’s not feasible. And there are a lot of states like that where we have personnel that need to be able to audit and they can’t.”

“How do you get the site that you’re auditing to work with you? It’s showing them that you’re willing to work with them.”

“A paper audit is never as effective as a virtual or on-site audit. A paper audit a lot of times can be used in conjunction with the on-site or virtual audit.”

Relevant Links

Leadership

Design Space InPharmatics - LinkedIn

Design Space InPharmatics - Twitter

Edward Narke on LinkedIn

Bettina Kaplan on LinkedIn