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FDA cGMP: Compliance Auditing (Sterile Pharmaceuticals)

Course Introduction

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 GMP audit.
The topics selected for this course include the basic compliance requirements for production and laboratory controls; the technical requirements such as aseptic validation and filtration, lyophilization technology, and HVAC and WFI systems; and the current issues including isolator technology, and microbiological environmental monitoring.

Course Outline

  • General Production Controls for Sterile Products 
  • Sterile Processing Equipment
  • Facilities/HVAC Design
  • Disinfection and Sanitization (D&S) Programs
  • Sterilization Parameters: F, D & Z
  • Class Exercise: F, D & Z
  • HEPA Filter Certification
  • Non-viable Environmental Controls
  • Microbiological Environmental Monitoring
  • Aseptic Filtration
  • Aseptic Processing Validation: Media Fills
  • Water-for-injection System
  • Lyophilization Technology
  • Isolator/Barrier Technology

Course Instructor

Mr. John Y. Lee


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