Certified Investigator Training

Virtual Learning

March 14 – 16, 2023

Course Overview

This training will be delivered via an instructor-led virtual classroom over three days.

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. On completion, delegates can participate in a short exam, consisting of deviation examples which will be independently assessed by our tutors for thoroughness of the investigation and the clarity of the written report

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

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.

Price: £1850 excluding VAT (where applicable)

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