Medical Device Professionals Learn Tips for FDA Compliance
Wednesday, May 5, 2010
UTICA, NY—Document what you do and do what you document; that was Ted Wilson’s advice to a room of 40 quality systems and regulatory affairs professionals last week at ConMed Corporation in Utica.
Wilson, partner at top international law firm Hogan & Hartson, presented tips for meeting tougher Food and Drug Administration (FDA) regulations at the seminar, CAPA: Preparing for an FDA Inspection on Tuesday, April 27. The program was organized by MedTech, the trade association that supports the growth and development of bioscience businesses in Upstate New York.
A recent report by FDANews found that a significant number of observations in FDA Form-483s and warning letters have to do with corrective and preventive actions (CAPA). Besides regulatory reasons, safety and business reasons also contributed to the significance of CAPA in FDA inspections.
"Companies need to consider and implement to ensure that they are becoming aware of, in a timely manner, quality and regulation issues in an organization, and take responsible corrective actions to address those issues,” Wilson said in the presentation.
Wilson offered tips for CAPA procedures in compliance with the FDA Quality System Regulation (QSR) in his two-hour intensive presentation. Some key tips included:
• Set priorities to increase efficiency in the CAPA process
• The analysis of product and quality problems should include statistical and non-statistical techniques
• The CAPA process should serve as a feeder into the management review process
The presentation was followed by a group exercise using hypothetical scenarios, and a panel discussion with members from MedTech’s Regulatory Affairs and Quality Systems Affinity Group followed by questions from the audience.
"Every encounter you have on behalf of your company makes a history with FDA,” Wilson said. An effective CAPA program will help the company maintain good relations and credibility with FDA in the long run.
For more information about the CAPA: Preparing for a FDA Inspection, 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. For more information, visithttp://www.medtech.org.