Annual Product Quality Review (APQR) and Annual Product Review(APR)

Venue: The Yorkland Hotel

Location: Toronto, Ontario, United States

Event Date/Time: Mar 23, 2010 End Date/Time: Mar 24, 2010
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Description

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)

Venue

185 Yorkland Boulevard
Toronto
Ontario
United States
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