Deviation investigation and CAPA in the pharmaceutical industry

This course focuses on root cause analysis and how to execute a successful CAPA management process from initial reporting to root cause analysis for the Pharmaceutical industry.

Course description

Inadequate non-conformance investigations remain one of the most frequently cited issues during regulatory inspections.
Common problems include unclear or unsupported root causes, weak corrective actions, and delays in addressing deviations. These shortcomings often result in repeated issues, leading to wasted time, money, and resources.

This course covers the full deviation management process:

• Initiation
• Investigation
• Design of corrective and preventive measures
• Impact assessment and follow-up
• Report writing

At each stage, we explore what to consider to avoid common pitfalls and ensure all necessary elements are included. Participants will also be introduced to several root cause analysis tools and will have the opportunity to practice using them during the course.

The training is interactive, combining theory with discussions, hands-on activities, and practical exercises.

Course outline

• Why is it important to investigate deviations?
• Reporting
  • Problem description, categorization, initial assessment
• Investigation
  • Root cause analysis
    • Tool
    • Human Error
    • Prove the root cause
• Actions
  • Corrections, corrective and preventive measures
  • How do you design a good action?
  • Impact monitoring
• Report
  • What should it contain?
  • How should it be written?
  • Deviation investigations: What do the authorities look at?

Learning objectives

After the course, the participants should be able to

• List information is important to document when reporting a deviation
• Demonstrate functional knowledge on a number of different tools, as well as combinations of them, to perform a root cause analysis
• Critically analyse an identified root cause and make an assessment whether it is supported by sufficient data
• Identify what constitutes a good measure
• Describe key considerations when summarizing the deviation report

Who should attend

The course is aimed at those who work in or close to pharmaceutical manufacturing and need a better knowledge of deviation investigations and CAPA. Perhaps you are the one who will lead the investigations, participate in the investigations or the one who reviews them. The course goes through the entire flow from initiation of a deviation to final reporting and is extra valuable for those who need to get a better overall picture of deviation investigations and what is important in each step, or those who want to refresh old knowledge.

Prerequisites

• You must have completed the Basic Course in GMP and Quality Systems or have equivalent prior knowledge
• You should have worked at least 6 months in GMP-regulated operations

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