Achieving and Maintaining Laboratory cGMP Compliance
Agenda: Day Two
VII. Good Documentation Practices
- Ensure the product life cycle is traceable by implementing good documentation practices in the laboratory
- Determine what must be recorded before, during and after testing
- Avoid typical errors (e.g., don't leave blank pages in a logbook to fill in later)
- Manage raw data appropriately
- Examine types of records – paper and electronic
VIII. Method Validation
- Interpret regulations, guidances and standards for method validation
- Identify types of analytical procedures to be validated (e.g., ID tests)
- Examine elements of validation of analytical procedures (specificity, linearity, range, accuracy, precision, detection limit, quantitation limit, robustness, system suitability)
- Implement best practices for method transfer
- Determine when, why and how to revalidate methods
IX. Out-of-Specification (OOS) Investigations
- Review the three main causes of OOS results
- Highlight the "cardinal rules" to be followed during any OOS investigation
- Outline the steps involved in an OOS investigation
- Utilize an OOS investigation checklist
- Carry out appropriate re-testing
- Implement needed corrective actions and follow-up
Exercise: View Sample 483s for OOS Handling and Reporting
X. Validation of Laboratory Computer Systems
- Review the purpose and objectives of computer system validation
- Examine elements of computer system validation (system design qualification, testing/installation qualification, operational qualification, documentation, change control/maintenance)
- Generate required documentation (e.g., validation protocol)
- Comply with 21 CFR Part 11
XI. Prepare for FDA Inspection and Avoid Regulatory Enforcement Actions
- Train personnel on what to do during an inspection
- Interact appropriately with FDA inspectors
- Identify and avoid common lab-related deviations
Exercise: Divide Into Groups and Role Play an Inspection
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.