Demystifying Your Questions on Revised Commissioning & Qualification ISPE Baseline Guide Vol. 5

Complimentary Extended Learning
Learning Level: Intermediate

This webinar session is a follow-up to last summer’s popular webinar, “Polishing an Old Gem: Commissioning & Qualification Baseline Guide Update” which gave participants an overview of the revised ISPE Baseline Guide. During the session, the speaker introduced tools to help projects drive efficiency and reduce duplication of commissioning and qualification efforts during execution.

We’ve gathered a team of experts to not only write a series of blogs posts to address your most frequently asked questions, but those same experts will gather to further answer your questions in a panel discussion in this townhall-style webinar.

Join us as the C&Q Webinar FAQ Task Team highlights key FAQs presented in the blogs and addresses new questions from the audience such as URS, Quality Unit, Risk Assessment, IT/GAMP 5, DR/DQ, and Periodic Review.

Learning Objectives

  1. Improve understanding of the process described in the new C&Q Guide
  2. Clarification of details in the Quality Risk Management (QRM) C&Q process as raised in the previous webinar
  3. Increase knowledge in the areas of URS, Quality Unit, Risk Assessment, IR/GAMP 5, DR/DQ and Periodic Review

Overview

Baseline Guide Vol 5: Commissioning & Qualification 2nd Edition


Speaker

Steven J. Wisniewski
Principal Compliance Consultant
CAI
Alexander A. Mendoza
C&Q Lead, Global Engineering
Takeda
Nicholas R. Haycocks
Senior Specialist QA
Amgen Inc
Nathan W. Temple
CQV Business Area Leader
CAI
Stephanie White
Sr. Manager, Engineering Projects
Amgen
Zachary Luce
Senior Consultant
Project Farma