Annual Product Quality Review (APQR) and Annual Report (AR)

Venue: Montreal, Quebec

Location: Montreal, Quebec, Canada

Event Date/Time: Dec 03, 2009 End Date/Time: Dec 04, 2009
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A Two day comprehensive course with workshops on:

- Annual Product Quality Review (APQR) - Interpret Health Canada’s regulatory requirements
- US FDA CFR 211, § 211.180
- ICH Annual Review Content
- Product Quality Review (EU GMP Guide)
- Annual Product Quality Review, AQPR (Canadian GMP) Vs. Annual Product Review (US, FDA)
- Developing Standard Operating Procedures (SOPs) - What should be included
- Best Practices for Writing AQPR Reports
- Proposed Chapters of a Product Quality Review (PQR)
- Documentation for APRs - Format and Methods of APR Documentation
- Implementing Best Practices for Writing Annual Reports
- Overview for CMC Section of Annual Reports
- CMC Section Table of Contents
- Quality-by-Design (QbD) paradigm and Annual Product Quality Review, (APQR) and Annual Reports (AR)