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Date: 10th - 11th June, 2008

Location: Toronto, Canada

Summary:
- Seminar

A ONE & ONE-HALF DAY COMPREHENSIVE & INTERACTIVE COURSE, WITH CASE STUDIES & WORKSHOPS ON:

- GMP and GLP Requirements for SOPs
- Regulatory Expectations of SOPs
- Definition & Objectives of SOPs
- Using and Integrating SOPs with other documents
- General Format and Components of SOPs
- Controlling Sequence of Actions
- Identifying Responsibility for Tasks
- Active vs. Passive Voice in Writing SOPs
- Determine target audience, how SOPs will be used
- Document Control
- Minimizing Design Overlap
- Assigning responsibility of preparation and management of SOPs
- GAP Analysis for SOP Systems
- Assessing SOP Effectiveness
- Peer & Formal Review
- Auditing of SOP Compliance
- 21 CFR Part 11 Issues
- Periodic Review