LTR podcast is a new monthly feature on Let’s Talk Risk!. Each month, we sit down with an industry leader to go deeper into Quality/Regulatory topics in MedTech to gain deeper, more actionable insights.
This month, we talk about FDA’s upcoming Quality Management System Regulation (QMSR) and inspection readiness with Vincent Cafiso. As an ex-FDA investigator, he offers a unique perspective on the medical device regulation amendments under QMSR, which are expected to go into effect very soon. Medical device firms operating in the US will most likely need to transition their Quality Management System (QMS) to comply with the amended regulation within 1 year of its final publication.
More importantly, we also discuss how QA/RA professionals, especially those who are new to MedTech, can continue to advance their careers in our rapidly changing industry.
Watch the full episode (approximately 76 minutes) or jump the topic of interest using the timestamps below:
Chapters
0:00:00 Introduction
0:06:09 Introduction to QMSR
0:19:10 Importance of Complaints Handling
0:29:35 Process based approach in QMSR
0:36:09 Inspection readiness and process engineering
0:46:52 An insider look on how FDA plans their inspections
0:52:30 Comparing FDA inspections with notified body audits
0:55:30 Trending towards more remote inspections
1:00:17 Career trajectory, and key milestones
1:08:06 Career advice for QA/RA professionals
1:10:55 Closing comments
About Vincent F. Cafiso
Vincent F. Cafiso started his career as an investigator at the US FDA, where he conducted hundreds of complex investigations at medical device and IVD manufacturers, both domestic and outside the United States. Subsequently, he spent over 25 years at leading medical device manufacturers helping them become inspection-ready through robust internal audit and compliance programs and a strategic focus on developing a culture of Quality. He is currently the Founder and Managing Consultant at Practical Compliance Results, LLC where he offers advisory services to clients in inspection readiness, compliance, quality assurance and quality systems consulting.
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