Healthcare 2020 - Root Cause Analysis - Starting at the Beginning
Date2020-11-10
Deadline2020-11-10
VenueOnline, USA - United States
KeywordsHealthcare; Pharmaceutical; Medical online training
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.
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.
Other CFPs
- Risk Based Verification and/or Validation to meet US FDA CGMP and ISO 13485 Requirements
- What You Need to Know: Auditing EU-MDR and EU-IVDR Implementation
- Knock, knock, who’s there? Are you ready for an FDA inspection in the COVID-19 Era and Beyond?
- A Critical Step in Risk-Based Approach to CSV, 21 CFR Part 11 and FDA Compliance
- Sterilization of Pharmaceutical Products and Medical Devices During COVID19 New Course
Last modified: 2020-10-24 18:54:50