S-05. GMP Compliance and Auditing for Sterile Pharmaceuticals

Course Description

This course reviews and interprets the current FDA compliance requirements for the production and control of sterile pharmaceuticals, and discusses the practical techniques for conducting an effective and efficient audit.

The topics selected for this course include the GMP compliance requirements for various aseptic processing controls; a compliance and technical review of aseptic filtration, lyophilization technology, and HVAC and WFI systems; and the current compliance issues for isolator technology, media fill, and microbiological environmental monitoring.

Learning Objectives

This course will provide the attendees with the GMP compliance and technical knowledge to evaluate the controls for sterile pharmaceuticals and ensure compliance with FDA requirements.

Who Should Attend

This course is intended for Compliance Auditors, Quality Assurance and Production professionals. Regulatory Affairs and Research and Development professionals involved in the support for sterile pharmaceuticals should also attend.

Course Outline

  • Sterile Product Processing Controls; Facilities and Equipment Design
  • Aseptic Gowning, Training and Techniques
  • Sterilization Parameters: Practical Applications of F, D & Z Values, Including Class Exercises
  • Designing, Validating and Revalidating Sterilization Cycles
  • Clean Rooms
    • Design and Classification, HEPA Filter Testing
    • Particulate Monitoring, Air Pressure Differential, Air Flow
  • Microbiological Monitoring for Sterile Operations
  • Disinfection and Sanitization (D&S) Programs
  • Aseptic Filtration: Review of Selected Compliance Issues
  • Media Fill: Validation Requirements and Recommendations
  • Water-for-injection System
  • Lyophilization Technology
  • Isolators