Documentation Management Strategies for GLP Compliance

Venue: Academy of Applied Pharmaceutical Sciences (AAPS)

Location: Toronto, Ontario, Canada

Event Date/Time: Dec 06, 2007 End Date/Time: Dec 07, 2007
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Description

A Comprehensive & Interactive One & Half Day Course and Workshop On:

- Reviewing GLP regulatory expectations
- FDA Warning Letters
- 21 CFR Part 11 requirements for GLP Documentation
- Effective Documentation Practices
- Management of Raw Data
- Deviations versus Amendments
- SOP Preparation
- Designing, Writing & Checking Protocols and Reports
- Preclinical, Clinical and Validation Documentation
- Protocol Writing and Review
- Writing and Reviewing SOPs and Work Instructions
- Proper Maintenance of Documentary Systems
- Policies, Records, Logs, Protocols, Forms, Work Instructions
- Documentation Content, Formats & Templates
- Strategies for Effective Writing
- Quality Manuals
- GDP and Change Management
- SOP Writing and Review
- Report and Data Review for Deviation and OOS Test Results
- Auditing Sample Documents

Distinguished Course Leader
Ms. Celeste Rose, RQAP-GLP

Venue