The course will be assessed and certified by RSSL against the standards of ICH Q7. By the end of the course you will be able to:
鈥nderstand the regulatory requirements for conducting API audits
鈥rovide background information and scope for a supplier audit
鈥reate a structured approach in preparation for an API audit
鈥onduct an API audit
鈥reate a check list of questions to ask
鈥dentify non conformities against ICH Q7 and regulatory expectations
鈥dentify product specific requirements
鈥ave knowledge of the basic manufacturing techniques and equipment used
鈥nderstand the requirements for Good Control Laboratory Practices (GCLP)
鈥roduce a report that will satisfy the sponsor organisation as to the ongoing status and compliance of the API supplier
鈥roduce a report that demonstrates the continuing suitability and certification of the API(s) in question
鈥now how to obtain auditee cooperation and acceptance of findings
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 (QPs) responsible for the release of pharmaceutical products.
鈥nderstand the regulatory requirements for conducting API audits
鈥rovide background information and scope for a supplier audit
鈥reate a structured approach in preparation for an API audit
鈥onduct an API audit
鈥reate a check list of questions to ask
鈥dentify non conformities against ICH Q7 and regulatory expectations
鈥dentify product specific requirements
鈥ave knowledge of the basic manufacturing techniques and equipment used
鈥nderstand the requirements for Good Control Laboratory Practices (GCLP)
鈥roduce a report that will satisfy the sponsor organisation as to the ongoing status and compliance of the API supplier
鈥roduce a report that demonstrates the continuing suitability and certification of the API(s) in question
鈥now how to obtain auditee cooperation and acceptance of findings
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 (QPs) responsible for the release of pharmaceutical products.
