Key Developments for Medical Device Inspections in the U.S. and Around the Globe: Are You Prepared?
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Key Developments for Medical Device Inspections in the U.S. and Around the Globe: Are You Prepared?

12/7/2017
When: Thursday, December 7th
2:00 pm ET
Where: United States
Contact: Sheri DeVinney
202-354-7171


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On Thursday, December 7th at 2pm ET, MDMA will present an important (no cost) member only webinar, Key Developments for Medical Device Inspections in the U.S. and Around the Globe: Are You Prepared?, presented by Nathan Brown and Howard Sklamberg, partners at Akin Gump Strauss Hauer & Feld LLP.


Nathan Brown and Howard Sklamberg, partners at Akin Gump Strauss Hauer & Feld LLP and co-authors ofWorld of Change Coming for Device Manufacturers: Developments in FDA and International Inspections, will discuss important developments for medical device inspections and the implications for device manufacturers.

 

Nate and Howard will highlight three recent and important initiatives: FDA’s Program Alignment, the FDA Reauthorization Act of 2017, and the Medical Device Single Audit Program, all recently implemented by FDA and Congress to improve regulatory efficiency and predictability in the inspection of medical device facilities. You will learn how your company can constructively engage with these new programs and effectively reap the benefits of each, how these changes can offer medical device-makers opportunities to streamline and enhance your compliance and quality programs, and how to leverage these programs as FDA explores ways to collaborate with other regulators around the world as a result of the rapid growth of globalization of medical device production.