Critical Documentation Control for Laboratory Operations

Venue: AAPS

Location: North York, Ontario, Canada

Event Date/Time: Aug 10, 2009 End Date/Time: Aug 11, 2009
Registration Date: Aug 10, 2009
Early Registration Date: Jul 11, 2009
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Description

A One & Half Day Comprehensive and Interactive Workshop On:
- Understanding GLP Regulatory Expectations for Documentation
- 21 CFR Part 11 requirements for GLP Documentation
- FDA Warning Letters
- Effective Documentation Practices
- GDP and Change Management
- Proper Maintenance of Documentary Systems
- Designing, Writing & Checking Protocols and Reports
- Effectively Preparing Standard Operating Procedures (SOPs)
- Policies, Records, Logs, Protocols, Forms, and Work Instruction
- Management of Raw Data
- Deviations versus Amendments
- Preclinical, Clinical and Validation Documentation
- Protocol Writing and Review
- Developing and Using Formats & Templates
- Effective Writing Skills
- Quality Manuals
- Reporting and Data Review for Deviations and OOS Results
- Auditing Sample Documents

Venue

AAPS
200 Consumers Road, Suite 200
North York
Ontario
Canada
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