Quality Risk Management Commissioning & Qualification: Key Deliverables & Lessons Learned Webinar

Extended Learning
Learning Level: Intermediate
Time: 1000 – 1200 ET
Session Length: 2 hour

It Is Approaching Two Years since Publication of the 2ND Edition Commissioning & Qualification (C&Q) Ispe Baseline Guide. Since That Time the C&Q ISPE Communities of Practice Has Developed Examples of Some of the Key Deliverables Associated with the Qrm C&Q Process and Experience Has Been Gained by the Industry in How to Implement Those Deliverables and Mistakes to Be Avoided. This Webinar Will Provide a Quick Review of the Qrm C&Q Process Flow Followed by a More Detailed Focus on the User Requirement Specification, the System Risk Assessment, Design Review/Design Qualification, Acceptance and Release, and C&Q Planning. Each Key Deliverable Presentation Will Include an Overview, a Review of Lessons Learned, an Example from the Examples Team, and Some Q&a Time.

Learning Objectives

  • Participants will gain a better understanding of the key deliverables for the QRM C&Q Process.
  • Knowledge gained from a review of the lessons learned can be translated implementing a more efficient QRM C&Q process at your individual site.
  • Examples shown will provide context and insight on how the scope and content of the deliverables influence and support the process flow to achieve systems and equipment fit for intended use.

Speakers

Steven J. Wisniewski
Principal Consultant
CAI
Paul J. Meehan, Jr., CPIP
Director QA Validation
Ultragenyx
Hazem Eleskandarani, PE
Senior Director, Global Engineering Quality
CSL Behring
Taha Jalal
Senior Validation Engineer
Freelancer

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