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.
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.
