CAPA Investigations - Tools for a Compliant and Effective Investigation Process

Why Should You Attend:

A central theme in every CAPA investigation is determination of reoccurrence. Reoccurrence of deviations, non-conformances, or incidents may be indicative of inadequate investigations and/or ineffective identification of CAPAs. Tracking and trending is the process by which reoccurrence is determined and adequacy of the CAPA system as a whole is demonstrated. This webinar has been specifically designed to delineate the essential elements of CAPA investigations.

Areas Covered in the Webinar:

• International regulatory requirements for CAPA investigations
• Insight into investigator or auditor expectations from CAPA investigations
• Essential elements of CAPA investigations
• Roles and responsibilities for CAPA investigations

Who Will Benefit:

This CAPA investigations webinar will provide professionals from pharmaceutical, biotechnology, medical device and active pharmaceutical ingredient industries with the necessary tools to investigate non-conformances and deviations. It will be of interest to personnel directly involved in completing, reviewing or approving investigations. Expected participation by:

• Quality Engineers
• Manufacturing Engineers
• Quality Systems Managers
• Operations Managers
• Regulatory Compliance professionals
• Consultants

Instructor Profile:

Carlos A. Rodriguez-Garcia, PhD, ASQ CSSGB, CBA is president of BioMed Pharma Consulting, LLC, an independent consulting firm providing services in quality management systems to the pharmaceutical and medical industries. Mr. Rodriguez-Garcia has over 15 years of experience in the regulated industry, the vast majority in quality management, encompassing a wide scope of products and processes: plastics, parenterals and aseptic processes. His experience includes conducting and approving CAPA investigations as well as training investigators in root cause analysis techniques and proper documentation of CAPA investigations to comply with FDA and EU requirements.

Topic Background:

CAPA investigations are a systematic documented process by which product quality is assured and risk to patient safety is mitigated. Investigations may arise from multiple sources, such as deviations from procedures, product non-conformances, component non-conformances, complaints, or incidents identified from the production process. The central element of a CAPA investigation is the root cause analysis. It is from the determination of root cause in a CAPA investigation that corrective and preventive actions are identified to assure product quality and improve process performance. Multiple investigation methods have been developed to identify root cause and establish effective corrective and preventive actions. The model introduced by Ishikawa (also known as fishbone diagram) is considered as one of the most robust methods for conducting root cause analysis. An adaptation, based on the assessment of the 6Ms (Man, Machine, Methods, Materials, Measurement, and Mother Nature- i.e., Environment), will be presented as a methodology for identifying true or most probable root cause to determine corrective and preventive actions.

CAPA investigations are comprised of multiple elements, of which the salient ones are:

• Description of the Problem (Problem Statement)
• Product Impact (Criticality and Corrections)
• Root Cause Investigation
• Corrective Actions and Preventive Actions
• Effectiveness Plan

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