Writing, Operating & Managing the SOP for GMP Operations

Venue: Radisson Hotel Toronto East

Location: Toronto, Ontario, Canada

Event Date/Time: Sep 25, 2006 End Date/Time: Sep 26, 2006
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Description

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

- Reviewing and understanding regulatory expectations
- Defining the role of SOPs in GMP compliance
- What is required to establish a sound documentation function within your work arena
- Determining what SOPs need to be written
- Writing an effective compliant SOP
- Critical components of procedures and work instructions
- Formatting of SOP - What makes SOPs clear, succinct, unambiguous & easy to understand
- Consistency in format and terminology
- Performing gaps and overlap analyses on SOP Systems
- Managing the SOP system including its costs
- SOPs as an auditing tool
- SOP system administration
- SOP review, approval, and revision processes
- Document distribution, retrieval, and archiving
- Training requirements and training documentation

Interactive workshops on:

- Exercises in determining SOP needs
- Critiques of system deficiencies in existing SOPs
- Discussion of SOP system management
- SOP preparation - Applying the learned techniques to specific operations

Distinguished Course Leader

Dr. Alan J. Smith
pharmaceutical quality & technology consulting

PROGRAM CONTENT:
DAY ONE
Monday September 25th, 2006

- FDA expectations and findings for SOPs & the SOP system
- Role of SOPs in the total documentary system
- Role of SOPs in GMP compliance
- Detailed characteristics of SOPs and the SOP system
- Controls required for documents including SOPs
- Determining SOP needs and assigning preparers
- Analyzing existing SOP systems for gaps & overlaps
- Interactive Workshop
- SOP Classification
- SOP formatting techniques and templates
- Typing, printing and other publishing techniques for SOPs
- Techniques for clear and unambiguous writing
- Techniques for text minimization

DAY TWO
Tuesday September 26th, 2006
- Examples of different types of SOP
- Interactive Workshop
- Critiques and appraisals of SOPs
- Design, organization and management of the SOP system
- General aspects
- Optimizing SOP cost
- Use of SOPs for training and auditing
- SOP review, approval, and revision processes
- Document distribution, retrieval, and archiving
- SOP effectiveness measurement
- Roles and responsibilities
- Performing periodic reviews
- SOPs as an auditing tool
- Interactive Workshop Session
- Organizing an SOP from systems analysis findings

Venue

55 Hallcrown Place
Toronto
Ontario
Canada
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Additional Information

Registration Fee: $498.00 CAD + GST (6%) Students & Government employees 30% discount Registration Fee Includes: Presentation Materials, Luncheon, Refreshments and Parking

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