FDA Medical Device Inspections in the Post pandemic World

in this FDA News hosted webinar. Regulatory Compliance Associates® Inc.'s, Seyed Khorashahi, Executive Vice President and CTO, will share 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
About RCA
Regulatory Compliance Associates® Inc. (RCA) provides worldwide services to the following industries for resolution of compliance and regulatory challenges:
- Pharmaceutical
- Biologic & Biotechnology
- Sterile compounding
- Medical device
- Lab Testing
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.
- Founded in 2000
- Headquartered in Southeastern Wisconsin, with offices in West Central Florida; North Central Colorado; and Central Eastern Europe
- Expertise backed by over 500 industry subject matter experts
- Acquired by Sotera Health in 2021
www.rcainc.com

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