Course Scope:
This course provides the basic knowledge base and skills to enable effective auditing and reporting on audits of suppliers of active pharmaceutical ingredients (APIs). It focuses on the requirements of ICH Q7 and EU GMP Part II and the expectations of regulatory bodies both in the USA and Europe.
Overview:
The course will be assessed and certified by RSSL against the standards of ICH Q7. At the end of the course you will:
鈥nderstand the regulatory requirements for conducting API audits
鈥e able to provide background information and scope for a supplier audit
鈥ave the ability to create a structured approach in preparation for an API audit
鈥e able to conduct an API audit
鈥now how to create a check list of questions to ask
鈥e able to identify non conformities against ICH Q7 and regulatory expectations
鈥e able to identify 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now how to produce a report that will satisfy the sponsor organisation as to the ongoing status and compliance of the API supplier
鈥e able to produce 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.
This course provides the basic knowledge base and skills to enable effective auditing and reporting on audits of suppliers of active pharmaceutical ingredients (APIs). It focuses on the requirements of ICH Q7 and EU GMP Part II and the expectations of regulatory bodies both in the USA and Europe.
Overview:
The course will be assessed and certified by RSSL against the standards of ICH Q7. At the end of the course you will:
鈥nderstand the regulatory requirements for conducting API audits
鈥e able to provide background information and scope for a supplier audit
鈥ave the ability to create a structured approach in preparation for an API audit
鈥e able to conduct an API audit
鈥now how to create a check list of questions to ask
鈥e able to identify non conformities against ICH Q7 and regulatory expectations
鈥e able to identify 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now how to produce a report that will satisfy the sponsor organisation as to the ongoing status and compliance of the API supplier
鈥e able to produce 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.
