Course Outline
Day 1 - Problem Framing, Containment and Statistical Thinking
The investigation mindset in a pharma context and common pitfalls of investigations written for the auditor
Problem definition through structured techniques: Is/Is Not analysis, 5W2H, correctly framing the problem statement
Issue containment with clear differentiation between immediate, interim and permanent actions, plus a risk matrix for containment decisions
The distinction between special cause and common cause and its implications for CAPA selection
Basic statistical tools applied to pharma investigations: Pareto analysis, histograms, run charts
Control charts and the interpretation of Western Electric rules for process signals
Day 2 - RCA Toolkit, CAPA Selection and Integration
RCA toolkit and selection criteria between 5 Whys, Fishbone (Ishikawa) and Fault Tree Analysis based on case complexity
Correct application of each RCA tool, with emphasis on avoiding common pitfalls
Cause verification and root cause confirmation through data and replication, not through assumption
CAPA selection and the proportionality of actions relative to the type of root cause identified
Defining measurable effectiveness check criteria for CAPA and the most frequent reasons why CAPA become ineffective
End-to-end integration on a case study, from deviation through to CAPA with effectiveness check
Requirements
Audience
The course is designed to bring colleagues with different roles and varying degrees of involvement in the investigation process to the same level of understanding.
The typical audience includes specialists and managers from Quality Assurance, Quality Control, Production, Engineering and Validation, as well as people from support functions who contribute to deviations, complaints or CAPA.
The course is suitable both for those who lead investigations (investigation leads, QA specialists) and for those who contribute to them without being process owners, since the stated goal is to achieve a shared perspective on the investigation process, regardless of role
Testimonials (1)
Fun to talk
