Acceptance Activities in FDA QSR

Why Should You Attend:

FDA Warning Letters frequently cite acceptance activities among the top five sections cited. To avoid a Warning Letter, you must understand the regulations and effectively implement them. This presentation explains the requirements and uses Warning Letters to illustrate problems.

This QSR section plays a major role in purchasing and production. The steps determine if your suppliers sent the product you ordered and if production made the product you expect. The process also determines whether you could ship a finished device.

As in customary, acceptance activities require well-written procedures, trained employees, and correct quality records. In addition, there is a major role that involves sampling, §820.250(b), acceptance status, §820.86, and nonconforming product, §820.90.

As you ensure that your Quality Management System meets FDA’s regulations, you need robust acceptance activities. A gap could result in a Warning Letter, but even worse, it could also create a recall. Because you must have an effective process, this presentation provides the implementation information you need.

Areas Covered in the Webinar:

• Some of the specialized terms from QSR such as “establish” and “finished device”
• How purchasing and acceptance activities are linked and combine to facilitate effective supplier management
• Guidance on when In-process acceptance activities are required
• The required activities to release a finished device for distribution
• The acceptance activity records to keep and how they relate to Device History Record (DHR)
• The role of sampling plans in Acceptance Activities

Who Will Benefit:

People in the following roles can especially benefit from the information in this presentation:

• Design Engineers, especially those involved in Design Transfer
• Operations Managers
• Production Managers/Supervisors
• Purchasing Managers/Agents
• Quality Engineers
• Manufacturing Engineers

Bonus Material

Participants receive a checklist to help assure conformance with QSR requirements for Acceptance Activities

Daniel O Leary
President, Ombu Enterprises, LLC

Dan O’Leary is the President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. Dan 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 Master’s Degree in Mathematics; is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and holds an APICS certification in Resource Management.

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