Certified Investigator Training

This course covers all aspects of pharmaceutical investigations from defining and investigating the problem using root cause analysis tools to writing up the investigation and determining 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 three days. On completion, delegates can participate in a short exam, consisting deviation examples which will be independently assessed by our tutors for thoroughness of the investigation and the clarity of the written report.

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

• Critical steps when investigating incidents
• Pharmaceutical 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

• Introduction to investigations, defining the problem, organizing and analysing data
• Anatomy of a problem (error-chain), active vs. latent, problem-solving tools, facilitation skills
• Recording the investigation, decision-making, developing CAPAs, CAPA effectiveness, CAPA hierarchy
• Deviation trending

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