Monday, 7 October 2013

Acceptance Activities in FDA Quality Systems Regulation


Scheduled On : Thursday, October 10, 2013 at 10 AM PDT | 1 PM EDT
Duration : 90 Minutes

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Description :


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.



Level : Intermediate


Areas Covered in the Session :


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
 
Speaker Profile
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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