MedTech Seminar Addresses FDA Scrutiny
Thursday, April 22, 2010
SYRACUSE, N.Y.—With the Food and Drug Administration (FDA) enforcing tougher investigations and heavier fines, corrective and preventive action (CAPA) procedures are becoming a top priority for medical device, drug and biologics manufacturers—including those in Upstate New York.
Edward C. Wilson, Jr., partner at top international law firm Hogan & Hartson, will address FDA's current CAPA requirements at a presentation on April 27 at ConMed Corporation in Utica. Hosted by MedTech, the trade association that connects Upstate New York’s biomedical sector, Wilson will explore the essentials for any product that must meet the tougher FDA regulatory demands.
"Because of increased regulatory attention, CAPA is a topic of growing concern for companies in the bioscience industry,” said Heather Erickson, President of MedTech. “MedTech’s members recognize CAPA as a critical tool in continuous quality improvement.”
An analysis of recent FDA warning letters by FDANews found corrective and preventive action (CAPA) problems cited 18 times in 10 letters. According to Wilson, CAPA violations have become the most frequently cited items in FDA Form-483s and warning letters.
"FDA's concerns typically focus on the failure to operate a global CAPA system,” said Wilson. “An effective system should quickly detect and correct quality issues from all sources, and failure to do so may prevent companies from taking appropriate actions.”
The seminar, CAPA: Preparing for an FDA Inspection, will focus on FDA's current requirements and expectations for implementing and maintaining effective CAPA systems, and will provide practical tips for meeting these challenges.
CAPA: Preparing for an FDA Inspection will be held Tuesday, April 27 from 3 to 5 p.m. at ConMed Corporation, 525 French Road, Utica. This event is open to the public; registration is $50 for MedTech members and $60 for non-members. To register, visit http://www.medtech.org, or call 315-423-7200.
For more information about MedTech or this event, contact Jill Zimmerman, (315) 410-7180.
MedTech is a not-for-profit trade association comprised of Upstate New York technology manufacturers, research institutions, allied professional services and economic development organizations. We promote the commercialization of medical products by providing educational and networking events, organizing certification opportunities and facilitating collaborations among members to bring tomorrow’s technologies to the healthcare marketplace. To learn more, visit http://www.medtech.org.