Writing Standard Operating Procedures (SOPs)
Agenda: Day Two
V. Recognize the General Controls Required for Documents Including SOPs
- List the main control systems for documents
- List the types of intra-document controls
- Determine the need for change control
VI. Determine Your SOP Needs and Assign Responsibility for Preparation and Management
- Determine the methods for analyzing SOP needs
- Describe the methods for minimizing overlap during design
- Analyze the methods for performing gap and overlap analysis for existing SOP systems
Exercise: Compile SOP Listings, and Perform Gap and Overlap Analysis
VII. Discuss the Management Aspects of Your SOPs
- Describe what needs to be managed
- Explain how SOPs can be used as training and auditing tools
- Describe various parameters to measure SOPs effectiveness
Exercise: Prepare an SOP on a System for Managing SOPs
VIII. Comply with 21 CFR Part 11
- Review requirements for e-records and e-signatures
- Identify potential gaps in compliance
- Implement controls to achieve and maintain compliance
IX. Analyze FDA Enforcement Trends
- Anticipate what FDA investigators are looking for in terms of SOPs
- Audit SOPs for compliance
- Avoid common pitfalls
Exercise: Examine Warning Letters Containing Citations for SOP Violations
Booking Options
This course is available exclusively as an onsite training solution. To discuss a solution that fits your organization's needs, objectives, schedule and budget, contact a PTi Client Solutions Manager at 800-303-8194 or OnSiteSolutions@pti-international.com.