A highly interactive and practical training course aimed at people working in the
pharmaceutical industry who are about to start auditing or those who already audit but
have no formal training. It provides an introduction to the guideline for Quality Management
Systems auditing specified in the international standard 19011:2002. Delegates will learn
and then practice how to plan, execute, report and close-out internal audits as well as write
non-conformity reports linked to a GMP clause.
The course focuses on EU GMP as an audit standard but the auditing techniques described
are applicable to other standards applied including CFR21 210 and 211; a range of other
standards appropriate to the pharmaceutical industry (PS 9000, GDP, ISO 9001) are
described briefly but not explored. The course will be assessed and certified by RSSL
in line with the requirements of its Lead Auditor course, which is certified by IRCA.
pharmaceutical industry who are about to start auditing or those who already audit but
have no formal training. It provides an introduction to the guideline for Quality Management
Systems auditing specified in the international standard 19011:2002. Delegates will learn
and then practice how to plan, execute, report and close-out internal audits as well as write
non-conformity reports linked to a GMP clause.
The course focuses on EU GMP as an audit standard but the auditing techniques described
are applicable to other standards applied including CFR21 210 and 211; a range of other
standards appropriate to the pharmaceutical industry (PS 9000, GDP, ISO 9001) are
described briefly but not explored. The course will be assessed and certified by RSSL
in line with the requirements of its Lead Auditor course, which is certified by IRCA.
