Invited Speakers: Overview of Current Trends in FDA Emergency and Recall Policy: Sandra Whetstone, Director, Division of Compliance Management and Operations, FDA
New SOPs: Reporting Corrections and Removals of Devices
Casper Uldriks, Consumer Safety Officer, CDRH, FDA
Steve Niedelman, Supervisor, Consumer Safety, CDRH, FDA
How to Deal with the FDA in Device and Drug Recalls: Michael J. Verdi, Consumer Safety Officer, CDRH, FDA
Bruce Parker, JD, Goodell, DeVries, Leach & Gray, LLP, Member, National Trial Team, Baxter Health Care Corporation Breast Implant Litigation
Meeting with FDA District Investigator(s) and Avoiding Field Alerts and Recalls: Managing Field Corrections
Steve Rochelle, Rochelle & Associates, and Marc Feinberg, VP, RA, Global Pharmaceutical, former FDA District Recall Coordinator
Senator Chris Dodd on the Dodd Recall Bill
Chairperson: David Seligman, Esq., Independent Counsel for Pharmaceuticals, Biologics and Devices; Consulting Counsel to Gibbons, Del Deo, Dolan, Griffinger and Vecchione
Program:
Special In-Depth half day workshop:
Develop the blueprint for a successful recall/successfully managing a recall: the first 48 hours
20+ industry professionals!
Registration :
contact: 800-856-2556 or 610-565-2622
Deadline for Abstracts: closed
Email for Requests and Registration: customer.service@parexel.com