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
Links Mentioned
Leadership
Design Space InPharmatics – LinkedIn
Design Space InPharmatics – Twitter
Edward Narke on LinkedIn
Bettina Kaplan on LinkedIn