Dates - 15th March 2012, 8th November 2012
Price - £580 + VAT
This course provides the basic knowledge base and skills to enable effective auditing and reporting of audits on those suppliers of Active Pharmaceutical Products.
The course is focused on the requirements of ICH Q7 and EU GMP Part and the expectations of regulatory bodies both in the USA and Europe
Suitability
The course is suitable for people who have had some auditor training and experience in conducting audits and 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 responsible for the release of pharmaceutical products.
Learning Outcomes
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:
Understand the regulatory requirements for conducting API audits
Able to provide background information and scope for a supplier audit
Create a structured approach in preparation for an API audit
Conduct an API audit
Create a check list of questions to ask
Identify non conformities against ICH Q7 and regulatory expectations
Identify product specific requirements
Have knowledge on the basic manufacturing techniques and equipment used
Understand the requirements for Good Control Laboratories Practices
Produce a report that will satisfy the sponsor organisation as to the ongoing status and compliance of the API supplier
Produce a report that demonstrates the continuing suitability and certification of the API(s) in question
Know how to obtain auditee cooperation and acceptance of findings
To book a training course, please download the booking form,
complete and email to bookings@rssl.com