Root Cause Analysis - Starting at the Beginning

Event Details

  • DateWed 18 August 2021
  • Time10:00 AM - 11:00 AM
  • VenueOnline
  • Location39658 Mission Boulevard Fremont National 9453
  • TypeWorkshop
  • Ticket$$ 149 per person
  • Table$Price for a table per table (seats Normally between 8-12)
  • ContactEvent Manager
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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.