This course provides an introduction to the requirements of systematic failure investigation and corrective and preventive action 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 investigative tools are explored to help build up knowledge of techniques that might be used to provide a structure for systematic investigation
of failure. Opportunities to try out simple techniques are provided throughout. Examples of the use of, and outputs from, more complex techniques are presented.
Register/FDA Guidance for Industry. The course is focused on company responsibilities within a Quality Risk Management system and several investigative tools are explored to help build up knowledge of techniques that might be used to provide a structure for systematic investigation
of failure. Opportunities to try out simple techniques are provided throughout. Examples of the use of, and outputs from, more complex techniques are presented.
