CGMP: Pharmaceutical CAPAs (GMP10)

Recorded Webinar | Kelly Thomas | From: Feb 18, 2021 - To: Dec 31, 2021

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Recording
⊖   ⊕$259  
DVD
⊖   ⊕$269  
Recording + DVD
⊖   ⊕$429  
Transcript (Pdf)
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Recording & Transcript (Pdf)
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This online training program describes corrective and preventive actions (CAPAs), and how good manufacturing practices can be applied to eliminate causes of non-conformities or other undesirable situations. The training program enables the students to interpret and identify the requirements of a pharmaceutical CAPA system. As a fundamental management tool, CAPA is integral to the effectiveness of a quality management system. The objectives of this course are to teach the requirements of ICH Q10- PQS (Pharmaceutical Quality System), describe escalation and tracking processes in a CAPA system, explain the importance of investigation and risk assessment, list a CAPA system's critical elements, explore the different processes and phases of a good CAPA system, and identify a CAPA system's regulatory requirements.

Learning Objectives:-

  • Identify the regulatory requirements for a CAPA system.
  • List the various phases and the processes of a successful CAPA system.
  • Explain the critical elements of a CAPA system.
  • Explain the importance of risk assessment and investigation.
  • Describe tracking and escalation processes in a CAPA system.
  • Recognize the requirements of ICH Q10 - Pharmaceutical Quality System (PQS).

Session Outline:-

Introduction

  • Welcome
  • Introduction
  • Overview
  • Pharmaceutical Quality System (PQS) Model
  • Key areas of the QMS
  • Reviews and assessments

Regulations

  • Overview
  • Compliant CAPA systems
  • Activity: Looking for CAPA requirements within GMPs
  • FDA QSIT inspections of CAPA systems
  • Important definitions
  • Examples of different CAPAs
  • Topic review

The CAPA System

  • Overview
  • Features of a CAPA system
  • CAPA flowchart
  • Phases of a CAPA system
  • Topic review

Elements of CAPA System

  • Overview
  • CAPA system inputs
  • Risk assessment and CAPA
  • Risk assessment process
  • CAPA documentation
  • The CAPA procedure
  • CAPA request/record
  • Correction/containment
  • Corrective action
  • Preventive action
  • Verification and closeout
  • Completed CAPA report
  • Topic review

Root Cause Analysis

  • Symptom or Root Cause?
  • When to conduct RCA/CAPA
  • Root Cause Analysis (RCA)
  • Investigation & Analysis

Tracking and Escalation

  • Overview
  • Progress tracking and escalation
  • CAPA trending
  • Topic review
  • Summary

Kelly Thomas

Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.

Utilizing strategic thinking, risk-based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.