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.
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.
