Preparation, Implementation and Management of SOPs

Strategies to Design and Execute Effective Policies and Procedures for Regulated Industries

An Important Two-Day Comprehensive & Interactive Course & Workshops on:

- Overview of Regulatory Requirements and cGMP/GMP/GLP
- The role of SOPs in Quality Documentation Systems
- SOP Maintenance
- Reviewing current SOPs to determine gaps and overlaps to strengthen the existing documentation system
- What procedures require SOP’s?
- Designing an SOP template
- The Team approach to SOP writing
- Defining responsibilities and knowing the audience
- Ensuring the flow of the document
- Writing tips for a concise, unambiguous document
- SOPs as an auditing tool
- Training of SOP’s and SOP’s as a training tool
- The Change Control System


Distinguished Course Leader

Dr. Alan Smith

Who should attend? This two day, interactive training seminar and workshop program is directed toward Directors, Managers, Supervisors, Analysts, and Associates in the Pharmaceutical, Biotechnology, Medical Device, and allied industries with daily responsibilities in the following areas: - Quality Control - Quality Assurance - Analytical development - Pharmaceutical Development - Change Control - Documentation - Training - Regulatory System Auditors - Regulatory Affairs - Manufacturing - Engineering/Maintenance - Materials Management - Process Development - Distribution - Vendors - Contract Suppliers Registration Fee: $575.00 + GST (6%) 25% Discount - for Health Canada and Government Employees, Full Time Students & Academic Faculty