Certified Investigator Training

Virtual Learning

November 23 – 26, 2020

Course Overview

The instructor-led virtual sessions run at European AM times.

This course covers all aspects of investigations from defining the problem, investigating the problem using root cause analysis tools, to writing up the investigation and defining the corrective and preventive actions (CAPAs) using the CAPA hierarchy and CAPA effectiveness.

This course is suitable if you investigate incidents, approve deviations or if you work in quality control and perform out of specification investigations. The training will be delivered via an instructor-led virtual classroom over four days. On completion, participants can provide three of their investigations to NSF for assessment and expert feedback, ensuring there is evidence of the effectiveness of the training.

These investigations may be redacted to maintain confidentiality for an independent assessment of the thoroughness of the investigation and the clarity of the written report.

Key Learning Objectives

At the end of this training, delegates will know and understand:

  • Critical steps when investigating incidents
  • Root cause analysis tools
  • The CAPA hierarchy
  • Types of investigations, complaints, recalls, out of specification (OOS) and out of trend (OOT) investigations
  • How to write up a clear and concise investigation

Course Outline

  • Module 1 - Introduction to investigations, defining the problem, organising and analysing data
  • Module 2 - Anatomy of a problem (error-chain), active vs latent, problem-solving tools, facilitation skills
  • Module 3 - Recording the investigation, decision-making, developing CAPAs, CAPA effectiveness, CAPA hierarchy
  • Module 4 - Deviation trending
  • Module 5 - Types of investigations, complaints, recalls, OOS/OOT

Course Coach

Vicky Baulch has worked in the pharmaceutical industry for over 20 years in multiple companies and has a passion for patient safety, risk management and continuous improvement. She is a practising QP, and very experienced at investigating deviations and making sure they are rigorously investigated before approval. Vicky is an enthusiastic trainer who loves to share her experience.