Webinar:
"Oops – we have a problem!" Part 2:
Root Cause Analysis (RCA), CAPA,
Effectiveness Check
Issues , deviations , non-compliance management.
Root Cause Analysis (RCA), CAPA,
Effectiveness Check
Issues , deviations , non-compliance management.
July, 23 | 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
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What will you get:
The attendees will get better clarity about what is coming
with the E6(R3) in terms of CAPA management
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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:
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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 ShevaldyshevMD, 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