C4A – Root Cause Analysis – Starting at the Beginning

When:
November 13, 2019 @ 10:00 am – 11:00 am
2019-11-13T10:00:00-08:00
2019-11-13T11:00:00-08:00
Where:
webinar

https://www.compliance4all.com/webinar/root-cause-analysis—starting-at-the-beginning–502683LIVE

By John E Lincoln

$150

CAPA and the related actions of Failure Investigation and Root Cause Analysis (RCA) is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities.

A compliant CAPA system is required to to “close-the-loop” complaints, non-conformances, out-of specification conditions, and must also include proper impact analysis / actions. As such CAPA is a major element of cGMP compliance (one of the four key inputs of QSIT, the FDA’s Quality Systems Inspection Technique), and is also a key source of regulatory problems.

How can companies allocate scarce resources to those activities that have the greatest impact to product quality / safety, minimize resources on minor issues, and still satisfy the regulatory agencies? Use the proper Failure Investigation, Root Cause Analysis methodologies, not just to satisfy regulatory requirements, but to facilitate a closed-loop problem resolution system to reduce “fire fighting” and minimize costly product quality problems.

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