Course Outline
Day 1 - Problem Framing, Containment and Statistical Thinking
Navigating the investigation mindset in a pharmaceutical context and addressing common pitfalls in documentation intended for auditors.
Defining problems through structured techniques: Is/Is Not analysis, the 5W2H method, and accurately formulating problem statements.
Managing issue containment with clear distinctions between immediate, interim, and permanent actions, supported by a risk matrix for decision-making.
Understanding the difference between special cause and common cause variations and their impact on selecting appropriate CAPA strategies.
Applying fundamental 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—5 Whys, Fishbone (Ishikawa), or Fault Tree Analysis—based on case complexity.
Correctly applying each RCA tool while avoiding common implementation pitfalls.
Verifying causes and confirming root causes through data validation and replication, rather than assumption.
Selecting CAPA measures that are proportional to the type of root cause identified.
Establishing measurable effectiveness criteria for CAPA and identifying frequent reasons for their failure.
Executing an end-to-end case study integration, moving from deviation reporting through to CAPA implementation and effectiveness verification.
Requirements
Audience
This course is tailored to align colleagues from various roles and levels of involvement in the investigation process, ensuring a unified understanding across the organization.
The typical attendees include specialists and managers from Quality Assurance, Quality Control, Production, Engineering, and Validation, as well as personnel from support functions involved in managing deviations, complaints, or Corrective and Preventive Actions (CAPA).
The program is equally beneficial for investigation leads and QA specialists who direct the process, as well as contributing team members who are not process owners. The primary objective is to cultivate a shared perspective on investigation methodologies, regardless of individual roles.
Testimonials (1)
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