Loader
Course Image

Course Description

Failure Investigation and CAPA 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.

Failure Investigation and CAPA 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...

Read More

Related Courses