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.
Run time: 33:50mins
CMC004 - Quality Assurance and Auditing in the Age of Covid-19 - Bettina Kaplan
Video Credit: DSI, a PLG Company
Takeaways:
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
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FDA CMC regulations and guidance simplified through examination, real life experiences and risk-based advice. This podcast hopes to educate sponsors and individuals on agency related regulatory CMC matters. We will focus on the critical CMC issues and build programs that enhance drug development. CMC topics will include Regulatory Starting Materials, API and Drug Product Process, Formulation Development, Supply Chains, Analytical Controls. Advocating and interpreting CMC Strategy, directing CMC Operations and Quality Assurance oversight in conjunction with developing CMC submission content that represents the best interests of emerging biotech. NOT INTENDED TO BE PRESCRIPTIVE ADVICE BUT RATHER INTERPRETATION THAT IS RIGHT FOR YOU. Since 2007 we have provided our partners with innovative strategies and exceptional advice intended to enhance program development, product approval, and marketing presence.