Acceptance Activities under the FDA's QSRs Webinar
This course will review the general procedural requirements for acceptance activities, and will discuss the role risk management and process validation play in developing valid and defendable product acceptance and release program.
This course will help you confirm that your acceptance activities are compliant with 21 CFR 820.80 and 820.86, and will further help you understand the additional QSR and Risk Management activities that support the development of receiving and in-process acceptance activities.
The confirmation that products meet established specifications prior to distribution is critical to ensuring a safe and effective device. Acceptance activities play an important role in this confirmation, while presenting manufacturers with the challenge of determining what to test, how it should be tested, what sample sizes are most appropriate for each attribute and what activities should be documented to demonstrate released product conforms to specifications.
Why Should you Attend:
People working in quality, operations and production management must attend this course because acceptance activities are an important part of the product release process, whether the goods are manufactured in-house or are procured from an outside source. Understanding how the Quality System Regulations support the development of acceptance criteria, and how those activities should be documented and justified is an important part of product realization.
Objectives of the Presentation:
Key learning objectives of this course include:
- Understanding what the procedural requirements are for acceptance activities
- Understanding the difference between outsourced product acceptance and in-process acceptance
- Developing and monitoring the right specifications for a good product acceptance program
- Leveraging Risk Management and Design Transfer to develop a strong acceptance program
- Understanding the role of statistical techniques in the development of acceptance activities
- The importance of good documentation practices and the development of a strong Device History Record.