Location

Productivity and Quality Institute - Alexandria

Objectives

• The purpose of the annual product quality review course is to educate the participant in • the regulatory requirements for the FDA Annual Product Review • demonstrating the power of the Periodic or Annual Product Review as a Quality Assurance and Quality Improvement tool. • Discussion 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.• It is also necessary to know that the regulatory requirements of different countries are different and hence this will further guarantee the quality of the pharmaceutical product.

Outcomes

Product Quality Reviews or Annual Product Reviews of drug products are required by the most guidelines. If used effectively, these reviews can be a powerful Quality Assurance tool. The Product Quality Review Process includes: Process Performance and Product Quality Monitoring, Corrective Action/Preventive Action, Change Management and Management Review which are enablers identified in ICH Q10, The Pharmaceutical Quality System

Course Contents

• The regulatory requirements for the Annual Product Review• The Annual Product Review as part of a contemporary Quality System• What should be included in the Product Review• The Product Review as a source of recommendations for process improvement• Management involvement and responsibility• The Product Review in support of stage 3 of process validation, continued process verification• The Product Review process as a user of, and contributor to, the corporate knowledge• The challenges of preparing a Product Quality Review for a product which is produced and tested by contractors.