Are You Ready for New Approaches and Methods?
In this FDA News hosted webinar. Regulatory Compliance Associates®, 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.
- 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
Executive Vice President, Medical Device and Chief Technical Officer
Regulatory Compliance Associates®
Regulatory Compliance Associates® (RCA) provides healthcare consulting 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, Health Canada, MHRA and globally-regulated companies.
As your partners, we can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.
- Founded in 2000
- Headquartered in Wisconsin (USA)
- Expertise backed by over 500 industry subject matter experts
- Acquired by Sotera Health in 2021
About Sotera Health
The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.
Sotera Health Company, along with its three best-in-class businesses – Sterigenics®, Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.
We are a trusted partner to more than 5,800 customers in over 50 countries, including 40 of the top 50 medical device companies and 8 of the top 10 pharmaceutical companies.
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