Course Outline
Day 1 - Problem Framing, Containment and Statistical Thinking
Understanding the investigation mindset within a pharmaceutical context and avoiding common pitfalls in reports intended for auditors.
Defining problems using structured techniques: Is/Is Not analysis, 5W2H method, and correctly framing the problem statement.
Implementing issue containment with clear distinctions between immediate, interim, and permanent actions, alongside a risk matrix to guide containment decisions.
Distinguishing between special cause and common cause variations and understanding their implications for selecting CAPA.
Applying fundamental statistical tools to pharmaceutical investigations: Pareto analysis, histograms, and run charts.
Utilising control charts and interpreting Western Electric rules to identify process signals.
Day 2 - RCA Toolkit, CAPA Selection and Integration
Selecting Root Cause Analysis (RCA) tools—such as 5 Whys, Fishbone (Ishikawa), and Fault Tree Analysis—based on case complexity.
Correctly applying each RCA tool, with a focus on avoiding common pitfalls.
Verifying causes and confirming root causes through data and replication, rather than assumption.
Selecting appropriate CAPA based on the proportionality of actions relative to the identified type of root cause.
Defining measurable criteria for checking CAPA effectiveness and identifying frequent reasons why CAPA measures fail.
Executing end-to-end integration through a case study, covering the journey from deviation reporting through to CAPA implementation and effectiveness checks.
Requirements
Audience
The course is designed to align colleagues from various roles and levels of involvement in the investigation process, bringing them to a common understanding.
Typical participants include specialists and managers from Quality Assurance (QA), Quality Control (QC), Production, Engineering, and Validation, as well as personnel from support functions who contribute to deviations, complaints, or Corrective and Preventive Actions (CAPA).
The course is equally suitable for those who lead investigations (such as investigation leads and QA specialists) and for those who contribute without being process owners. The primary goal is to foster a shared perspective on the investigation process, irrespective of individual roles.
Testimonials (1)
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