QRM Based Integrated C&Q Series - Qualification Strategies and Acceptance and Release
Complimentary
Learning Level: Intermediate
Time: 1000 - 1100 ET
Session Length: 1 hour
A risk-based qualification strategy can reduce the amount of testing required while ensuring systems are fit for intended purpose. This can improve compliance and accelerate project timelines. The keys are in the management of the documentation throughout the phases of design and installation, developing a testing strategy and plan, managing discrepancies during testing, and meeting requirements to accept and release systems after testing is complete.
The ISPE Baseline Guide Volume 5, Second Edition, supports risk-based qualification strategies to reduce the level of qualification testing commensurate with the mitigation of risk to product in the system design.
This webinar will demonstrate how to effectively plan and execute qualification testing and how to manage and prepare documentation for acceptance and release of systems. We will explore
- Introduce the principles and concepts of the documentation required for successful risk-based qualification testing and offer examples of how to manage those documents
- Overview of the prerequisites required to ensure successful qualification testing
- Real-World examples of proven strategies to successfully use engineering testing performed in commissioning to represent qualification testing
- How prepare qualification testing for acceptance and release
Attendees will gain actionable insights on strategies to reduce overall qualification testing that supports acceptance and release of systems. This session is ideal for engineering, quality, and validation professionals involved in the qualification and acceptance and release of pharmaceutical manufacturing equipment and systems.
Objectives
- Understand the principles, concepts, and documentation for successful qualification testing.
- How to navigate qualification testing when systems are in various phases of installation.
- Understand the requirements to complete the Acceptance and Release Phase
