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| Category |
Health: Professions
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| Category 2 |
Science: Chemistry
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| Category 3 |
Science: Biotechnology
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| Description |
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)
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