Annual Product Reviews/Product Quality Reviews

Duration: 12 Hours
Course Instructor

Danielle DeLucy, M.S.

$ 2330
Discounts: We offer a 10% group discount when you register 2 or more attendees (up to 10). Contact us for groups over 10.

Course description

View Course Outline

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:

  • Interpret the requirements for Annual Product Reviews.
  • Outline the role of the Product Review in corrective actions, preventive actions, and continuous improvement.
  • Outline systems that may be involved in the preparation of the product Review
  • Classify the role of management in an effective Product Review Program.
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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as defined in the FDA 2011 Process Validation Guidance and those who want to understand the potential impact of the FDA draft guidance on Quality Metrics on Product Reviews and the organization as a whole.

Course Instructor


Danielle DeLucy, M.S.

Owner, ASA Training & Quality Consulting LLC

Danielle DeLucy, M.S.’s Courses


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