QRM Based Integrated C&Q Series - New Program Initiation, Objections, Audit Defense

Complimentary
Learning Level: Intermediate
Time: 1100 - 1200 EST 
Session Length: 1 hour

This webinar will focus on the transition from a traditional program to a new, integrated qualification and compliance (C&Q) program. We will acknowledge the hybrid nature of the current program and discuss how to effectively move away from the V model. Additionally, we will address strategies for overcoming internal resistance to adopting the C&Q program outlined in the ISPE Baseline Guide, Volume 5, with a particular emphasis on preparing for audits post-implementation.

  • Understand the major elements of ISPE's current best practice to C&Q: QRM based integrated C&Q. Including an overview of the multiple planned ISPE webinars in 2025.
  • Implementation approach and transitioning from your current program to a new program
  • Overcoming objections and concerns while preparing your organization for a future audit defense of the approach.

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Speakers

Michael Lanasa
Associate Director Global Quality Compliance
Merck & Co Inc
Nathan Temple
CQV Business Area Leader
CAI