PTI - international

VII. Properly Maintain Facilities and Equipment

• Identify FDA requirements for maintenance and design of facilities
• Develop meaningful maintenance practices
• Overcome problems associated with clean rooms
• Define documentation requirements
• Address environmental monitoring
• Implement calibration and preventive maintenance programs

VIII. Utilize Proven Solutions for Laboratory Controls

• Maintain sample control and analyze certain statistical techniques
• Outline notebook documentation
• Ensure data integrity and efficiently review and approve data
• Explain data/sample retention

Exercise: Manage Missing Laboratory Data During an FDA Inspection

IX. Understand Design Control

• Review principles and concepts of good design control
• Identify requirements and applicability
• Employ practical considerations

Discussion: Define Design Criteria

X. Establish and Maintain Non-Conformance Programs

• Establish audit authority and organization
• Establish and define audit group scope and frequency
• Present complaint handling and relationship to non conformances and CAPA
• Learn when to submit a MDR or ADE report
• Implement results-based follow-up procedures including corrective action plans
• Conduct failure and OOS investigations and differentiate from re-testing
• Use preventive action techniques including trending and FMEA

Exercise: Identify Corrective Actions to Take in Response to a Provided Warning Letter

XI. Ensure 21 CFR Part 11 Compliance

• Clarify the FDA's new approach to Part 11 enforcement
• Guarantee electronic data integrity and security

Exercise: Part 11 Compliance Case Study

XII. Analyze Current FDA Expectations to Minimize Deficiencies

• Identify current FDA trigger points and compliance trends
• Interpret cGMP/QSR-related 483s
• Analyze current FDA inspection programs
• Minimize approval withholdings
• Protect against legal sanctions and prevent recalls

Exercise: Analyze Recently Issued FDA Warning Letters