FDA Warning Letters frequently cite acceptance activities, suggesting that device manufacturers may have implementation problems. This section is in the top ten Warning Letter citations. To avoid a 483 and a Warning Letter, you must understand the QSR requirements and implement them. This presentation explains the regulation, guides you to take action, and uses Warning Letters to illustrate problems.
This section plays a major role in both purchasing and in production. It is a major contributor to determine whether your supplier and manufacturing process are working effectively. Acceptance activities determine whether you can release finished goods for distribution.
Effective 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.
Objectives of the Presentation:
- Learn some of the specialized terms from QSR
- Understand how purchasing and acceptance activities are linked and combine to facilitate effective supplier management
- Provide guidance on when in-process acceptance activities are required
- Understand the required activities to release a finished device for distribution
- Know the acceptance activity records to keep and how they relate to Device History Record (DHR)
- Understand the role of sampling plans in acceptance activities
- Know the competence requirements for people who perform acceptance activities
Why Should you Attend:
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. This presentation provides the implementation information as well as the audit strategy to help verify your processes.
Participants receive a checklist to help assure conformance with QSR requirements for Acceptance Activities
Mr Dan O'Leary,
Ombu Enterprises, LLC
Dan has more than 30 years of experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. Mr. O’Leary has a Masters Degree in Mathematics, focusing on logic and number theory. His professional experience relates to quality, regulatory, reliability, and operations management.
He is a regular speaker at international conferences including ASQ, ISM, and RAMS. Dan teaches courses in reliability methods, medical device regulations and practices, statistical methods, management systems (ISO 9001, FDA QSR, & ISO 13485), and project management. He 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.
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
- Production Supervisors
- Purchasing Managers
- Purchasing Agents
- Quality Managers
- Quality Engineers
- Manufacturing Engineers