This fully virtual introductory course covers how to detect, identify, and prevent microbial contamination—specifically designed for non-microbiologists.

• Overview of bioprocessing (drug substance) and sterile manufacturing (drug product). Terminal sterilization versus aseptic production
• Most common microbial contaminants in bioprocessing and aseptic operations
• Microbial contamination detection methods including bioburden, sterility, and endotoxin testing
• Environmental Monitoring for viable and non-viable particles. Alert and Action levels.
• Microbial identification methods and technologies
• Sanitization, disinfection, and sterilization methods
• Biological indicators
• Aseptic technique and best practices for working with LAF/BSC hoods
• Case studies on microbial contamination events
  • Root cause analysis (RCA) and CAPA plans

8:30 a.m. to 12:30 p.m., EST

Registration fee: $150

Track A is a one-day, in-person course covering contamination control strategies (CCS) in CGMP bioprocessing environments for drug substance (DS) and bulk API production. The day will be split between a lecture covering the essential contamination control knowledge for drug substance manufacturing and aseptic technique practice and RCA/CAPA exercises. As the pharmaceutical industry continues to evolve and face new challenges, the CCS has become a critical pharmaceutical quality document.

• Lecture Topics
  • Contamination control and detection strategies
    • Focus on equipment, facilities, process, materials, clean utilities, and personnel
  • Equipment cleaning – CIP and COP
• Hands-On Activities
  • Aseptic technique and operations in a LAF/BSC hood
  • Contamination case studies/troubleshooting contamination events
    • Root cause analysis (RCA) and CAPA plans
  • Learn how to develop a contamination control strategy using quality risk management
    • Overview of key regulatory and industry guidance documents including EU Annex 1 (2022/2023), PDA TR#90, and ICH Q10.

January 26, 2027

Registration fee: $975

Track B is a one-day, in-person course covering contamination control strategies in aseptic/sterile, fill-finish, drug product (DP) environments. The day will be split between a lecture covering the essentials of aseptic environments, environmental monitoring techniques, and aseptic technique practice and RCA/CAPA exercises.

• Lecture Topics
  • Sterile Fill Finish – Aseptic processing concepts and controls
  • Cleanroom design and classification
  • RABS and Isolators – design and controls
  • Air visualization/smoke studies
  • Media fills
  • Sterile filtration concepts
  • EM during aseptic processing
  • Aseptic gowning/qualification
  • Personnel monitoring
  • Depyrogenation concepts
  • Container Closure Integrity Testing
  • Filter integrity testing
• Hands-On Activities
  • Perform filter integrity tests
  • Aseptic technique and operations in a LAF/BSC hood
  • Case studies – Sterility test failure and media fill failure investigations
    • Root cause analysis (RCA) and CAPA plans
  • Learn how to develop a contamination control strategy document using quality risk management
    • Overview of key regulatory and industry guidance documents including EU Annex 1 (2022/2023), PDA TR#90, and ICH Q10.

January 27, 2027

Registration fee: $975