Dates - 21st - 22nd September 2010
Price - £1160 + VAT
Scope
It is a regulatory requirement for organisations to audit API manufacturers, suppliers of key excipients & 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, PS9000 and 9100, GCLP and ISO 17025. Several elements of Quality Management Systems (ISO9001) 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.
Suitability
The course is suitable for people who have already undertaken some auditing (usually internal auditing) and who are now wishing or being asked to perform external audits.
Knowledge
By the end of the course you will be able to:
- Understand the benefits of external audits
- Initiate an Audit
- Create a structured audit programme
- Conduct an opening and a closing meeting
- Create a check list of questions to ask
- Write non conformity reports linked to an ISO 9001 clause
- Appreciate the importance of reporting and follow up
- Know how to behave to avoid conflict and gain auditee acceptance of findings.