CAPA - Best Practices and Common Pitfalls for FDA Regulated Industries


Instructor: Sue Jacobs
Product ID: 700137
Training Level: Intermediate to Advanced

  • Duration: 60 Min
This CAPA session will discuss these common pitfalls and share best practices, strategies and techniques on how to deal with CAPA system in relation to Warning Letters and 483 citations. In 2005 greater than 50% of FDA Warning Letters and 483 citations were CAPA related.


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Read Frequently Asked Questions

Many firms face similar challenges; aging CAPAs, failed effectiveness checks, an inadequate procedure, an ineffective method for prioritization, CAPA system too complex, and lack of management support. This session will discuss these common pitfalls and share best practices, strategies and techniques on how to deal with them.

What Attendees will Learn:

  • FDA Inspection trends related to CAPA,
  • Common CAPA pitfalls and how to avoid them,
  • How to overcome conflicting priorities and competing resources,
  • How to deal with aging CAPAs,
  • Why effectiveness checks fail and what to do about it,
  • Tips on how to escalate issues for management support,
  • Integrating risk management to leverage positive results,
  • Unique challenges and expectation for global manufacturers.

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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