Course Outline
Day 1 - Problem Framing, Containment and Statistical Thinking
Understanding the investigation mindset in a pharmaceutical context and avoiding common pitfalls often found in reports prepared for auditors.
Defining problems through structured techniques: Is/Is Not analysis, 5W2H, and properly framing the problem statement.
Managing issue containment with clear distinctions between immediate, interim, and permanent actions, along with a risk matrix to guide containment decisions.
Distinguishing between special cause and common cause variation and understanding its implications for selecting appropriate CAPA measures.
Applying basic 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
Selecting the appropriate Root Cause Analysis (RCA) toolkit—choosing between 5 Whys, Fishbone (Ishikawa), and Fault Tree Analysis based on case complexity.
Correctly applying each RCA tool, with a strong emphasis on avoiding common errors.
Verifying causes and confirming root causes through data analysis and replication, rather than reliance on assumptions.
Selecting CAPA measures that are proportional to the type of root cause identified.
Establishing measurable effectiveness criteria for CAPA and identifying the most frequent reasons why CAPA initiatives fail.
Executing an end-to-end integration exercise using a case study, moving from deviation reporting through to CAPA implementation and effectiveness verification.
Requirements
Audience
The course aims to align colleagues from diverse roles and varying levels of involvement in the investigation process toward a common understanding.
Typical attendees include specialists and managers from Quality Assurance, Quality Control, Production, Engineering, Validation, as well as personnel from support functions who contribute to deviations, complaints, or CAPA processes.
The program is suitable for both those who lead investigations (such as investigation leads and QA specialists) and those who contribute without owning the process, with the overarching goal of fostering a shared perspective on the investigation workflow regardless of individual roles.
Testimonials (1)
Fun to talk
