This webinar will explain FDA QSR requirements for acceptance activities related to medical device manufacturing. It will analyze recent Warning Letters and provide tips to ensure that your acceptance activities fully complies with the regulatory requirements.
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.
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
Course Provider
Daniel O Leary,
