Webinar:
"Oops – we have a problem!" Part 2:
Root Cause Analysis (RCA), CAPA,
Effectiveness Check

Issues , deviations , non-compliance management.
July, 16 | Wednesday
18:00 CET | 90 mins
Participation is free
This webinar (Part 2 of a two-parts series) will cover the updates related to the CAPA management in clinical trials as per the recently published and soon to become effective ICH GCP E6(R3) guideline
  • What will you get:

    The attendees will get better clarity about what is coming

    with the E6(R3) in terms of CAPA management

  • For whom:

    Clinical research professionals working in / with the countries where the ICH GCP E6(R3) will be launched soon, or who are otherwise interested getting the information about the E6(R3) changes in issues / deviations / non-compliance management (including Serious Breaches, Root Cause Analysis, CAPA)

Key elements:
  • We can exhale – impact assessment and immediate actions including reporting are done! Is there anything next?
  • Why did the problem occur? Why should we bother? Root Cause Analysis (RCA) – a waste of time or a valuable investment into quality?
  • Corrective Actions and Preventive Actions (CAPA) – call for risk proportionality – a long-awaited relief?
    CAPA Effectiveness Check – the doom is back?
Speaker
  • Oleg Shevaldyshev

    MD, MRQA, MCC Champion
    Quality and Training Director at The QARP
    • Independent Clinical Research QA Consultant, globally
    • 22 years of GCP experience, including 13 years in QA
    • Non-compliance and serious breach management
    • Issues / risk management
    • Process improvement / QMS management
    • ISO certificates (9001:2015, 10002:2014, 19011:2018, 31000:2018)
    • Publications in RQA Quasar
    • MCC Champion award for contributions around CAPA and Risk management
What You’ll Learn
  • This webinar (Part 2 of a two-parts series) will cover the updates related to the CAPA management in clinical trials as per the recently published and soon to become effective ICH GCP E6(R3) guideline, including:
  • Risk proportionality for the CAPA
  • Importance of proper RCA
  • Effectiveness Check – now mandatory for all CAPAs
  • Do’s and Don’ts

Join the expert discussion

and update your knowledge