Medical Device Workshop on FDA Inspections, Warning Letters, & CAPA
May 22 – 23, 2012 — Sheraton Crystal City, Crystal City, VA
FDA investigators are being more forceful when inspecting firms, increasing the number of 483 observations resulting in more warning letters. CAPA system deficiencies counted for a large number of inspectional observations and continue to be cited in FDA warning letters. The percentage of CAPA system deficiencies in FDA warning letters has increased in the past five years.
This conference will provide you the tools to avoid warning letters, enable you to demonstrate your compliance initiatives, and teach you how to respond to a warning letter. Learn how to properly integrate and implement your CAPA program to improve internal processes and products and better achieve business objectives.
Network with a distinguished panel of experts for an in-depth examination of what CAPA is, how the concept has evolved, and whether it accomplishes what industry needs and what FDA expects. Educational sessions, open discussions, and breakout assemblies on practical applications will help you implement and improve your CAPA systems.
"I found the CAPA seminar and slides very informative and interesting and the topic was very relevant to activities my company is working on addressing on a global level right now. I am planning to use information pulled from our slide handouts to help support our direction and actions in several areas that have been under discussion with our management team."
"As a person supporting a very small sales force for a small start-up and I found it very useful as I have become immersed in multiple roles. While, I am new to the medical device industry and struggled with some of the terminolgy, I'm sure all of the other attendees were very comfortable with all topics. The speakers were credible and knowledgeable. I thought their presentations were well worth my time away from the office"
Sara E. Dyson, Esq., Assistant Vice President, Medmarc
Karin Gregory, MPH, Managing Partner, Furman Gregory Deptula
Michael Heyl, Partner, Hogan Lovells
David R. Kalins, Consumer Safety Officer, Special Assistant to the Director of the Office of Compliance, CDRH
Walt Murray, Director of Quality and Compliance Services, MasterControl, Inc.
Jeffrey K. Shapiro, Director, Hyman, Phelps, McNamara, P.C.
Steve Slader, Director of Quality Engineering, International Technidyne Corp.
Melissa Torres, Biomedical Engineer, Office of Compliance, CDRH
Jennifer Zachary, Associate, Covington & Burling LLP
Hotel & Meeting Logistics
Sheraton Crystal City
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