Webinar on FDA Medical Device Regulation – Overview of Corrective Action/Preventive Action (CAPA) Requirements Friday – 28th June, 2013 - 2:00 PM EDT | 11:00 AM PDT Presented By : Sheila J. Ramerman, RAC, Founder, SJR Associates While the FDA understands that things don’t always go according to plan, they fully expect you to have a program that effectively resolves discrepancies and eliminates the possibility of recurrence (Corrective Action), as well as a program that identifies potential discrepancies/product problems and addresses them prospectively (Preventive Action). This overview covers the FDA’s CAPA regulations, how to develop an effective CAPA system, root cause analysis and investigation documentation. The presentation will cover the following areas: -Why do I need a CAPA system? -What makes a CAPA system effective? -The CAPA Process -CAPA Records -Computer-assisted CAPA Who Should Attend: CEOs, VPs, Directors, Heads, Managers working within: -Corrective/preventive action recall activities -Especially R&D personnel -Manufacturing personnel -QA/RA personnel Anyone interested in an overview of the FDA’s CAPA requirements. To register and RSVP, please visit : biopractice/webinar/web6/signup.php For any further assistance, please send an email to marketing@biopractice or call us : 1-646-216-8860
Posted on: Tue, 25 Jun 2013 06:18:32 +0000
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