Certified Investigator Training

Virtual Learning

March 14 – 17, 2022

Course Overview

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

The live sessions are run at European PM times to make them more accessible for participants in the US and some other time zones.

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, participants can provide three of their investigations to NSF for assessment and expert feedback. Assessment will include the thoroughness of the investigation and clarity of the written report, ensuring there is evidence of the effectiveness of the training.

These investigations may be redacted to maintain confidentiality.

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.

Price: £1800 excludiing VAT (where applicable)

Multiple Delegate Discounts are available for delegates from the same company attending the same course.

The first delegate must pay full price. The second delegate will receive a 20% discount. The third and any subsequent delegates will receive a 50% discount. Charities, NHS staff and Regulatory Bodies are entitled to a 50% discount. (Proof will be required).

View the Full Course Description