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Recorded Webinar
Key Element of Quality Management System Compliance
timelapse 60 min with 10-15 Mins of Q and A
Note:
This webinar occured in the past
Along with recorded webinar, copy of presentation slides will be shared
Recorded Webinar can be played unlimited times
Speaker/Presenter
Short Abstract
CAPA is a complete system that collects information regarding existing and potential quality problems.
It analyses and investigates the issues to identify the root cause of nonconformities. CAPA is not just a quick-fix, simple approach.
It is a process and has to be understood throughout organizations.
The CAPA system is second to none in terms of frequency and criticality of its deviations, and most of the regulatory actions taken by the FDA and foreign regulators are linked to inadequate CAPA systems.
Understanding the CAPA system is a fundamental prerequisite to improving it. Investigating and discovering the root cause of any event is just the starting point of the CAPA journey.
Areas Covered in the Webinar:
- Understanding CAPA relationship with QMS
- Regulatory requirements for CAPA
- Stepwise implementation of CAPA
- FDA views on CAPA
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