Quality Assurance and Auditing in the Age of Covid-19 with Bettina Kaplan
Effective Strategies for Early Stage Drug Development with Judy Magruder
August 14, 2020
Pharmaceutical Regulations in CMC with Dr. Catherine Bernard
August 28, 2020
Episode Summary
Design Space InPharmatics Senior Quality Assurance Consultant, Bettina Kaplan joins the show to share her experience with quality assurance and auditing in the pharmaceutical industry. In this episode, Ed, Brian, Meranda and Bettina discuss the impact that Covid-19 has had on auditing and how it has shifted the industry to focus on virtual audits. Bettina speaks to trends in quality auditing and the risks associated with not having audits done regularly.
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. Click To Tweet 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. Click To Tweet 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… Click To Tweet 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. Click To Tweet 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. Click To TweetLinks Mentioned
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