HEALTHCARE TRAINING 2020 - Root Cause Analysis - Starting at the Beginning

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Category HEALTHCARE TRAINING 2020

Deadline: November 10, 2020 | Date: November 10, 2020

Venue/Country: Online event, U.S.A

Updated: 2020-09-28 19:41:58 (GMT+9)

Call For Papers - CFP

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.

Why you should Attend: Expectations for meaningful, results driven CAPA (Corrective and Preventive Action) System that addresses and resolves underlying product problems are increasing among regulatory agencies world wide, with good reason.

Design Control (CGMPs and ISO), EU’s MDD / MDR, ISO 14971 (Device Risk Management) and the FDA’s QSIT and Q9, underscore this increased emphasis. A valid closed-loop CAPA system utilizes root cause analysis for true problem (not symptom) resolution.

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