Course Outline
Day 1 - Problem Framing, Containment and Statistical Thinking
Developing an investigation mindset suitable for the pharmaceutical context and identifying common pitfalls in reports intended for auditors.
Defining problems using structured techniques: Is/Is Not analysis, 5W2H, and properly framing the problem statement.
Implementing issue containment with clear distinctions between immediate, interim, and permanent actions, alongside a risk matrix to guide containment decisions.
Understanding the difference between special cause and common cause variations and how this impacts CAPA selection.
Applying fundamental statistical tools to pharmaceutical investigations: Pareto analysis, histograms, and run charts.
Utilizing control charts and interpreting Western Electric rules to identify process signals.
Day 2 - RCA Toolkit, CAPA Selection and Integration
Choosing the appropriate Root Cause Analysis (RCA) toolkit—5 Whys, Fishbone (Ishikawa), or Fault Tree Analysis—based on the complexity of the case.
Correctly applying each RCA tool while focusing on avoiding common errors.
Verifying causes and confirming root causes through data and replication rather than assumptions.
Selecting CAPA actions that are proportional to the type of root cause identified.
Establishing measurable criteria for checking CAPA effectiveness and understanding the most common reasons why CAPAs fail.
Executing an end-to-end integration on a case study, walking through the entire process from deviation to CAPA and its effectiveness verification.
Requirements
Audience
This course aims to align colleagues from diverse roles and varying levels of involvement in the investigation process, ensuring a shared understanding across the group.
The typical participants include specialists and managers from Quality Assurance, Quality Control, Production, Engineering, and Validation, as well as personnel from support functions who handle deviations, complaints, or CAPA processes.
The program is ideal for both those who lead investigations (such as investigation leads and QA specialists) and those who contribute to them without being the primary process owners, as the goal is to foster a unified perspective on the investigation process, irrespective of individual roles.
Testimonials (1)
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