Setting up a QSR Compliant CAPA System

Establishing a CAPA system is a requirement of the FDA quality system regulation for medical devices. This Webinar will discuss the key elements of an effective CAPA system, what needs to be addressed in written procedures, and CAPA documentation.

What Attendees will Learn

• What are the elements of an effective CAPA system,
• Understand the difference between corrective action and preventive action,
• Strategies to analyze multiple data sources to identify product, process and quality system problems,
• Techniques to establish action limits for CAPA,
• When to use basic quality tools,
• Strategies for achieving regulatory compliance for CAPA documentation.

Who Will Benefit:

• CAPA Managers
• Quality professionals
• Regulatory professionals
• Operations and Engineering personnel

Instructor Profile:

Sue Jacobs, is the Principal Consultant for QMS Consulting, Inc. specializes in US FDA compliance with medical device quality and regulatory requirements. Ms. Jacobs has more than 19 years experience in the medical device industry. She assists manufacturers and suppliers in developing and maintaining compliant quality system programs. She has served as a quality system expert witness on behalf of the US Food and Drug Administration. Ms. Jacobs is serving on the Board of Directors for the American Society for Quality (ASQ). She participated in FDA/Industry Grassroots Task Force meetings which implemented the program to pre-announce FDA inspections, annotate FDA Form 483s, and send close out letters after inspections. She also was a member of the Advisory Committee that wrote AdvaMed’s Points to Consider When Preparing for a QSIT Inspection. Ms. Jacobs is a member of the Regulatory Affairs Professional Society (RAPS), faculty member for AAMI’s GMP and Industry Practice Course and frequent speaker at educational programs for AdvaMed MTLI, MD&M, FOI Services and Management Forum Ltd.

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