Course Outline
Day 1 - Problem Framing, Containment and Statistical Thinking
Understanding the investigation mindset in a pharmaceutical context and identifying common pitfalls often found in reports prepared for auditors.
Defining problems through structured techniques: Utilizing Is/Is Not analysis, 5W2H, and proper problem statement formulation.
Effective issue containment: Clearly distinguishing between immediate, interim, and permanent actions, along with a risk matrix to guide containment decisions.
Differentiating between special cause and common cause variations and understanding their impact on CAPA selection.
Application of fundamental statistical tools in pharmaceutical investigations, including Pareto analysis, histograms, and run charts.
Interpreting control charts and applying Western Electric rules to identify process signals.
Day 2 - RCA Toolkit, CAPA Selection and Integration
Selecting the appropriate Root Cause Analysis (RCA) toolkit—choosing between 5 Whys, Fishbone (Ishikawa) diagrams, and Fault Tree Analysis based on case complexity.
Correct application of each RCA tool, with a focus 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 evaluating CAPA effectiveness and identifying frequent reasons for CAPA failure.
End-to-end integration through a case study, tracing the process from deviation detection to CAPA implementation and effectiveness verification.
Requirements
Target Audience
This course aims to align colleagues from diverse roles and varying levels of involvement in the investigation process, bringing everyone to a common understanding.
The typical audience comprises specialists and managers from Quality Assurance, Quality Control, Production, Engineering, and Validation departments, as well as personnel from support functions who contribute to deviations, complaints, or Corrective and Preventive Actions (CAPA).
The course is suitable for both those who lead investigations (such as investigation leads and QA specialists) and those who contribute without owning the process. The primary objective is to foster a shared perspective on the investigation process, irrespective of individual roles.
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