CAPA / RCA / Investigations Training Course

CAPA / RCA / Investigations Training Course (T73)

Overview

CAPA and Continuous Improvement using Process Performance & Product Quality Monitoring (PPPQMS), are elements of the Pharmaceutical Quality System (PQS), supported by ICH Q10. By practicing effective CAPA and PPPQMS a Pharmaceutical Quality System can realize Quality Management Maturity. Through lecture and “hands-on” team exercises this course illustrates how a mature Pharmaceutical Quality System utilizes CAPA and Continuous Improvement, how to effectively write and investigate to achieve holistic CAPA, and what PPPQMS can do for your PQS.

Included in the Quality Management Maturity (QMM) Certificate

 
The Quality Maturity Management (QMM) Certificate Program—offered through the ISPE Academy—equips professionals with the knowledge and tools to build, assess, and continuously improve quality systems that go beyond baseline compliance. This program provides a comprehensive foundation in Good Manufacturing Practices (GMP), Quality Risk Management (QRM), Root Cause Analysis (RCA), Corrective and Preventive Actions (CAPA), and Quality Management Maturity (QMM) as defined by global regulatory expectations, including the FDA's QMM initiative. Learn More and Register

Included in the Quality Essentials Certificate Program

 
The Quality Essentials Certificate Program provides a comprehensive foundation in the core principles, processes, and expectations that underpin a robust pharmaceutical quality system. Designed for professionals working in or entering GMP-regulated environments, this multi-course program builds a deep understanding of quality events, controlled documentation, and the supporting quality elements essential for sustaining compliance, data integrity, and operational excellence throughout the product lifecycle. Learn More and Register

Learning Objectives:

ICH Q10, ICH Q7, 21CFR 211 regulatory framework and linkage to the Pharmaceutical Quality System

Understanding the importance of how CAPA and Continuous Improvement integrate with the Pharmaceutical Quality System

Understanding Quality System Management Maturity

  • Where and how does Management Responsibility fit in
  • What are the enablers of a Pharmaceutical Quality System and how they work

How to Perform Holistic and Effective Correction and CAPA

  • Effective Deviation Authoring
  • Investigation for True Root Cause
  • Correction and CAPA

Product Performance and Product Quality Monitoring System (PPPQMS)

  • Product & Process Understanding & Tools​
  • ​Monitoring and Continual Improvement

ICH Q10 Pharmaceutical Quality System

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What You Will Learn

  • To author an effective investigation
  • Perform holistic correction and CAPA
  • Reduce deviations through risk based continuous improvement

Resources and Activities

APQ Guide: Corrective Action & Preventive Action (CAPA) System

APQ Guide: Cultural Excellence

APQ Guide: Management Responsibilities & Review (MRR)

PQLI Guide: Part 4 - Process Performance & Product Quality Monitoring System

Who Should Attend

  • Quality Assurance
  • Tech Support
  • Tech transfer functions
  • Operations functions
  • Early career (3-5 years within the industry)
  • Qualified persons in Europe
  • Team Lead/Operator/Technician Staff
  • Managers
  • Section heads
  • Supervisors and CEOs
  • President
  • Owner or General Manager working in pharmaceutical and biotech manufacturing (not CMO)
  • Engineering
  • Architecture or construction
  • Service provider or consulting
  • Equipment or material supplier

Additional Course Information

Communities of Practice

This training course is of particular interest to existing and future members of the Regulatory and Quality Networking Communities.

Training Notifications

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This course may also be delivered as Custom Training for your team.

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Daily Schedule and Pricing

This course is not currently scheduled, but may be offered at your company site. Please contact ISPE for more information
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