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CAPA and Root Cause Analysis Training

  • CAPA and root Cause Analysis training

    This trainer-led course provides an overview of the regulations and guidance relating to Corrective And Preventative Actions (CAPA) and Root Cause Investigations for medical devices manufacturing, explores CAPA system requirements, Event Investigation Flow within the CAPA process and CAPA Effectiveness, including the use of process monitoring and AQL and c=0 sampling approaches. It also sets out a risk-based approach to the root cause analysis process in line with ICH Q9. Techniques and tools for the analysis of situations and events that require root cause analysis are examined to provide a structured and comprehensive approach. Participants apply their learning through consideration of case studies based on real world scenarios.

  • Introducing GMP, Root Cause Analysis and Understanding Validation Training Programme

    The purpose of the Introducing GMP, Root Cause Analysis and Understanding Validation (3 Day) Training Programme is to provide learners with the opportunity of either taking one course alone, a mix of the following courses or all three in their entirety, over consecutive days.

    The complete programme allows learners to build a basic knowledge of GMP through to gaining an insight into Root Cause Analysis, and then on to understanding the requirements for Validation in the Healthcare Industry.

    The programme comprises Introducing GMP Training (Day 1), Root Cause Analysis Training (Day 2), and Understanding Validation Training (Day 3).