It is a regulatory requirement for organisations to audit active pharmaceutical ingredient (API) manufacturers, suppliers of key excipients and packaging materials, and contracted-out laboratory services. This course provides an introduction to the skills and processes necessary to perform effective external auditing and follows those details described in ISO 19011 - the international standard for auditing.
More specifically, the course focuses on those standards used by external suppliers to the pharmaceutical industry – EU GMP Part II, PS 9000 and 9100, GCLP and ISO 17025. Several elements of quality management systems (ISO 9001) are explored in detail which helps build knowledge
and confidence in this universally recognised standard on which many of the above are based. Delegates will learn and practice how to plan, execute, report and close-out external audits including writing non-conformity reports.
More specifically, the course focuses on those standards used by external suppliers to the pharmaceutical industry – EU GMP Part II, PS 9000 and 9100, GCLP and ISO 17025. Several elements of quality management systems (ISO 9001) are explored in detail which helps build knowledge
and confidence in this universally recognised standard on which many of the above are based. Delegates will learn and practice how to plan, execute, report and close-out external audits including writing non-conformity reports.
