Conducting Annual Product Review (APR)

Venue: Boston

Location: Boston, Massachusetts, United States

Event Date/Time: Dec 07, 2010 End Date/Time: Dec 08, 2010
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Description

Preliminary Outline:
GMP Requirements for Annual Product Reviews
FDA Inspections: Current Expectations for APR Programs
Implementing Best Practices for Writing Annual Reports – Integrating New Regulations with Traditional Requirements
Examining the Link between Annual Product Review (APR) and Annual Review (AR)
Determining the Overall Purpose of APRs
The Key Contents of an Annual Product Review
Applying Good Technical Writing Practices
Anticipate and avoid common citations related to APRs
Effectively Utilizing Tools to Interpret APR Results: Statistical Analysis of APR Data
Developing SOPs
APR Documentation
Making Sense of APR in the Quality by Design (QbD) Paradigm
Post-Approval CMC Changes – a Case for Science and Risk-based Approach
Identifying and Implementing Corrective and Improvement Actions
Personnel Responsibilities: Owner, Administrator and the APR Team

Venue