Periodic Product Quality Reviews or Annual Product Reviews of drug products are required by the U.S., EU, and Canada. The purpose of the annual product quality review course is to educate the participant in the regulatory requirements for the FDA Annual Product Review while demonstrating the power of the Periodic or Annual Product Review as a Quality Assurance and Quality Improvement tool.
We will discuss how the Product Review supports the US, EU, and Canadian GMPs while applying the ICH Q10, Pharmaceutical Quality System elements of Process Performance and Product Quality Monitoring, CAPA, Change Management, and Management Review. Discussions will also include the impact of the FDA 2011 Process Validation guidance and the potential impact of the proposed FDA requirement for Quality Metrics on the Product Review.
This intensive course will discuss the comparative evaluation of similarities and differences in requirements associated with the manufacturing of the drug product in different countries.
Upon completion of this course, you will be able to:
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This course is targeted toward professionals who are responsible for the preparation of the FDA Annual Product Review, or Product Quality Review, or the oversight of the preparation of the Product Quality Review.
This annual Product Quality Review course also includes information that is pertinent to those who support process validation as defined in the FDA 2011 Process Validation Guidance and those who want to understand the potential impact of the FDA draft guidance on Quality Metrics on Product Reviews and the organization as a whole.
When you need on-site attention, we’re not just here to help, we’re there to help—right by your side.
Individual courses are remarkably effective. But sometimes when you have a specific need, it helps to have expert guidance right in the room with you and your team.
In that case, we’re happy to design a custom training for your entire team, whether online—or on-site.
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