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.
“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.”
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