Role of the CDRH Ombudsman's Office
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10/26/2017
When: Oct 26, 2017
3pm ET
Where: United States
Presenter: Abiy Desta (CDRH Ombudsman) and Melissa Sage (CDRH Deputy Ombudsman)
Contact: Sheri DeVinney
202-354-7171


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On Thursday, October 26th at 3pm ET, MDMA will present an important (no cost) member only webinar, Role of the CDRH Ombudman's Office, presented by Abiy Desta (CDRH Ombudsman) and Melissa Sage (CDRH Deputy Ombudsman).

The CDRH Ombudsman’s office is an independent entity within CDRH that can facilitate in the resolution of scientific and regulatory disputes between companies and the Center, assuring fair and even-handed application of FDA regulations, policies, and procedures.  The presentation will walk MDMA members through the process of contacting the Office – beginning with what members can expect during an initial phone conversation to specific case studies and examples of the various methods used by the Ombudsman’s Office for resolving disputes and complaints.  The presentation will conclude with a discussion of the formal 21 CFR 10.75 Appeals Process and expectations for appeal meetings.

 

Click here for an archived audio version of this webinar.

Click here for a pdf copy of the webinar slides.