Acceptance Activities in FDA QSR



For device company Warning Letters in 2012, Acceptance Activities, 820.80, was the fourth most frequently cited QSR section. The trend continues in 2013. Not only are acceptance activities important for themselves, they link to many other QSR sections.

Acceptance activities can be hidden problems, waiting for an FDA Inspection to surface them. You don’t need to worry if you implement a solid program. This webinar guides you through the five subsections of 820.80 acceptance activities and explain how they integrate with other parts of QSR.

Areas to be Covered:

Attendees of Acceptance Activities will:
Develop an understanding of the parts of acceptance activities
Learn how to document acceptance activities as part of the 820.20(d) quality plan
Understand how to apply statistical techniques, especially sampling plans, to acceptance activities
Understand the fundamental linkage between purchasing controls and receiving acceptance
Understand how acceptance activities support the DMR and provide data for the DHR

Who will Benefit:

This webinar is a must for professionals in the device industry, including:
Quality Engineers
Production Managers
Production Supervisors
Quality Assurance and Quality Control
Quality Inspection and Test Managers
Purchasing Managers
Regulatory Affairs
Supply Chain Specialists

Dan O'Leary

Dan O’Leary, President, Ombu Enterprises, LLC, has more than 30 years experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a Masters Degree in Mathematics, focusing on logic and number theory. His professional experience relates to quality, regulatory, reliability, and operations management. Dan is an ASQ Certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; he holds an APICS certification in Resource Management.


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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance