Course Outline
Day 1 - Problem Framing, Containment and Statistical Thinking
The investigative mindset in a pharmaceutical context and common pitfalls encountered when documenting investigations for auditors.
Defining the problem 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, along with a risk matrix to guide containment decisions.
Differentiating between special cause and common cause variations and understanding their implications for selecting CAPA.
Application of basic statistical tools in pharmaceutical investigations: Pareto analysis, histograms, and run charts.
Understanding control charts and interpreting Western Electric rules to identify process signals.
Day 2 - RCA Toolkit, CAPA Selection and Integration
An overview of the Root Cause Analysis (RCA) toolkit and criteria for selecting between 5 Whys, Fishbone (Ishikawa), and Fault Tree Analysis based on case complexity.
Proper application of each RCA tool, with a focus on avoiding common errors.
Verifying causes and confirming root causes through data and replication rather than assumption.
Selecting CAPA measures with actions proportional to the type of root cause identified.
Establishing measurable effectiveness criteria for CAPA and understanding frequent reasons why CAPA may fail.
End-to-end integration exercise using a case study, covering the entire journey from deviation reporting through to CAPA implementation and effectiveness verification.
Requirements
Target Audience
The course is tailored to align colleagues from various roles and levels of involvement in the investigation process to a common level of understanding.
Typical attendees include specialists and managers from Quality Assurance, Quality Control, 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 beneficial for both those who lead investigations (such as investigation leads and QA specialists) and those who contribute without owning the process, as the primary objective is to foster a shared perspective on the investigation process regardless of individual roles.
Testimonials (1)
Fun to talk
