webinar

FDA Medical Device Inspections in the Post-pandemic World

About RCA
Regulatory Compliance Associates® Inc. (RCA) provides worldwide services to the pharmaceutical, biologic, sterile compounding, biotechnology, and medical device industries for resolution of compliance and regulatory challenges.

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Are You Ready for New Approaches and Methods?

In this FDA News hosted webinar. Regulatory Compliance Associates’s®, Seyed Khorashahi, Executive Vice President and CTO, shares the most likely medical device inspections scenarios and practical preparation strategies for unannounced FDA medical device inspections.

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 post-pandemic.

Prepare for all possibilities — traditional on-site, fully remote, or hybrid — with this webinar.

Webinar Takeaways:

  • 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

 

Keynote Speaker:

Medical Device Inspections

 

Seyed Khorashahi

Executive Vice President, Medical Device and Chief Technical Officer

Regulatory Compliance Associates® 

 

About RCA

Regulatory Compliance Associates® (RCA) provides worldwide services to the following industries for resolution of compliance and regulatory challenges:

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA-and globally-regulated companies.

As your partners, we can negotiate the potential minefield of regulatory compliance and private equity due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

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