FDA Medical Device Inspections in the Postpandemic World: Are You Ready for New Approaches and Methods? – Webinar Recording/Transcript
The FDA is ramping up its inspections of medical device manufacturing facilities. Will you be ready?
Since March 2020, the agency has focused on mission-critical inspections, but that’s about to change. As Omicron cases go down, the agency is expected to transition back to its normal inspection schedule, and it has a great deal of catching up to do.
Make no mistake: “normal operations” does not mean normal inspection methods. The FDA developed novel approaches to conducting inspections during the pandemic, including remote record reviews and other virtual activities. And it will undoubtedly continue using the most effective of these going forward, even postpandemic.
Prepare for all possibilities — traditional on-site, fully remote or hybrid — with this webinar.
Seyed Khorashahi, Executive Vice President and CTO of Regulatory Compliance Associates, will share the most likely inspection scenarios and practical preparation strategies.
- How to use a risk-based approach to inspection preparations
- How to prepare by establishing inspection hosting procedures and practicing readiness
- What to expect from the time the FDA investigators arrive until they leave
- What to do after the inspection
- What regulators may look for going forward into 2022
- What alternative tools the FDA may use for oversight of regulated products
Don’t get caught off guard when the FDA calls. Inspection success starts here.
Meet Your Presenter
Seyed Khorashahi is executive vice president of medical device and CTO at Regulatory Compliance Associates. He has more than 25 years of experience leading R&D teams in all aspects of developing safety-critical medical devices. Khorashahi has held leadership positions at Covidien (Medtronic), Baxter and Beckman Coulter, and has an extensive background in medical device product development, quality systems, regulatory affairs and mergers and acquisitions.
Who Will Benefit
- Regulatory personnel involved with inspections (vice presidents, directors, managers, etc.)
- Quality personnel involved with inspections (vice presidents, directors, managers, etc.)
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March 17, 2022