Good Documentation Practices for GMP operations

Venue: Hilton Garden Inn

Location: Montreal, Quebec, Canada

Event Date/Time: Mar 30, 2010 End Date/Time: Mar 31, 2010
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Understanding GMP Regulatory Expectations for Documentation
FDA Warning Letters
Standard Operating Procedures (SOPs)
Designing Protocols for Validation Studies, Stability Studies and Safety Studies
Master Formulae and Manufacturing Instructions
Forms, Reports, Batch Processing Records and Equipment Log Books
Tracking Information and Documents Using Identification Numbers
Effective Labeling Systems
Deviation Management and Failure Investigation
Corrective and Preventive Action
Change Management System
Product Quality Review and Annual Product Review
Control, Assessment and Revision of Documentation System
Quality Manuals
Effective Writing Skills
Auditing Sample Documents
Record Retention