When auditing Active Pharmaceutical Ingredient (API) manufacturers, there is a responsibility to ensure patient safety. This course provides the assurance required to meet both product safety and regulatory expectations.
This course provides the knowledge and skills to enable effective auditing and reporting of audits on suppliers of active pharmaceutical ingredients (APIs). The course is focused on the requirements of ICH Q7 and EU GMP Part II and the expectations of regulatory bodies both in the USA and Europe.
Who Should Attend
The course is suitable for people who have had some auditor training and experience in conducting audits. It is specifically designed for those responsible for assessing the content and findings of API audit reports as part of license applications and variations, as well as those Qualified Persons (QP) responsible for the release of pharmaceutical products.
This course provides the knowledge and skills to enable effective auditing and reporting of audits on suppliers of active pharmaceutical ingredients (APIs). The course is focused on the requirements of ICH Q7 and EU GMP Part II and the expectations of regulatory bodies both in the USA and Europe.
Who Should Attend
The course is suitable for people who have had some auditor training and experience in conducting audits. It is specifically designed for those responsible for assessing the content and findings of API audit reports as part of license applications and variations, as well as those Qualified Persons (QP) responsible for the release of pharmaceutical products.
