Community of Practice Group AQC Meetings

Posted in Metrics

The highly rated Community of Practice (CoP) groups meet as part of the AQC member program, sharing ideas and practical approaches to address challenges unique to each community. Members determine priority topics and share knowledge through case study presentations, panel sessions, and facilitated brainstorming sessions. The following three CoPs will meet in 2022 and discuss the following topics: 

  • Audit/Compliance/CAPA CoP
    • Opportunities and Challenges in the CAPA process
    • EU CTR: Practicalities for Implementing Serious Breaches
  • Inspection Readiness/TMF CoP
    • Case Study and Discussion: Risk-Based TMF Document Review
    • Accurate measurement of TMF completeness
  • QbD, RBQM, Quality Improvement (including centralized monitoring) CoP
    • Process Thinking When Identifying Risks and KRIs
    • RBQM and Data Management
    • MHRA Guidance and Categorizing Study Risk
    • QTLs and Companion KRIs

Meetings are open to all AQC Members, please visit the Knowledge Center calendar to register for upcoming meetings. An archive of past meeting recordings and presentations is available to Members in CoP-specific knowledge portals.