Course Scope
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.
Overview:
The course will be assessed and certified by RSSL in line with the requirements of its lead auditor course, which is certified by the International Register of Certified Auditors (IRCA). At the end of the course you will:
•Understand the benefits of external auditing
•Be able to initiate an audit
•Have the capability to create a structured audit programme
•Understand how to conduct an opening and a closing meeting
•Be able to create a check list of questions to ask
•Know how to write a non conformity report 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
Who should attend:
The course is suitable for people who have already undertaken some auditing (usually internal auditing) and who are now wishing or being required to perform external audits; it is also useful for Qualified Persons (QP) and managers who are responsible for, or recipients of, external supplier auditing and reports.
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.
Overview:
The course will be assessed and certified by RSSL in line with the requirements of its lead auditor course, which is certified by the International Register of Certified Auditors (IRCA). At the end of the course you will:
•Understand the benefits of external auditing
•Be able to initiate an audit
•Have the capability to create a structured audit programme
•Understand how to conduct an opening and a closing meeting
•Be able to create a check list of questions to ask
•Know how to write a non conformity report 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
Who should attend:
The course is suitable for people who have already undertaken some auditing (usually internal auditing) and who are now wishing or being required to perform external audits; it is also useful for Qualified Persons (QP) and managers who are responsible for, or recipients of, external supplier auditing and reports.
