It is a regulatory requirement for organisations to audit API manufacturers, suppliers of
key excipients and packaging materials and contracted out laboratory services. This course
covers the skills and processes necessary to perform effective external audits and follows
the processes described in ISO 19011 – the international standard for auditing. The course
focuses on the specific standards used by external suppliers to the pharmaceutical industry
– EU GMP Part II, PS9000 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.
This course is suitable for people who have already undertaken some auditing (usually
internal auditing) and now wish (or are required) to perform external audits; it is also useful
for QPs and managers who are concerned with supplier auditing. Delegates will learn and
practice how to plan, execute, report and close-out external audits including writing nonconformity
reports.
key excipients and packaging materials and contracted out laboratory services. This course
covers the skills and processes necessary to perform effective external audits and follows
the processes described in ISO 19011 – the international standard for auditing. The course
focuses on the specific standards used by external suppliers to the pharmaceutical industry
– EU GMP Part II, PS9000 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.
This course is suitable for people who have already undertaken some auditing (usually
internal auditing) and now wish (or are required) to perform external audits; it is also useful
for QPs and managers who are concerned with supplier auditing. Delegates will learn and
practice how to plan, execute, report and close-out external audits including writing nonconformity
reports.
