ResearchBib Share Your Research, Maximize Your Social Impacts
Sign for Notice Everyday Sign up >> Login

Healthcare 2020 - Root Cause Analysis - Starting at the Beginning

Date2020-11-10

Deadline2020-11-10

VenueOnline, USA - United States USA - United States

KeywordsHealthcare; Pharmaceutical; Medical online training

Websitehttps://www.compliance4all.com/webinar/r...503372LIVE

Topics/Call fo Papers

Overview:
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.

Last modified: 2020-10-24 18:54:50