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CPD Hours: 14
Classroom, online, in-house
This course provides an introduction to the requirements of systematic failure investigation (FI) and corrective and preventive action (CAPA) practices as described in ICH Q9 and made a regulatory requirement in Europe by Annex 20 of the Guide to GMP, and in the USA by the Federal Register/FDA Guidance for Industry.
The course is focused on company responsibilities within a quality risk management system, and several investigational tools are explored to help build up knowledge of techniques that might be used by a company to provide a structure for systematic investigation of failure. Numerous exercises are run throughout the course to provide realistic examples of events requiring investigation, providing an opportunity to practice investigation and writing up of corrective actions within teams. Examples of the use of, and outputs from, more complex techniques are presented.
This course includes the following topics :
By the end of the course you will be able to:
We offer a number of discounts and specials offers on our training courses including Group booking, NHS and Seasonal discounts.
A microbiologist with over 35 years experience, Andy Martin has worked in numerous QA management roles, spanning a range of sterile and non sterile dosage forms, and gained valuable experience in regulatory inspections, failure investigation, risk assessment and operational excellence activities including Lean Six Sigma Kaizen events.
Management of GMP inspections
This is a highly practical course covering management of GMP inspections from initial preparation, to hosting the actual inspection and follow up from the inspection