Instructor Led In-Person A-Z of Sterile Products Manufacture

Key Learning Objectives

Completion of this sterile products training course will enable you to:

Describe a typical sterile production process and the facility, equipment and utilities associated with sterile product manufacture

• Know what aspects require detailed definition, validation and ongoing monitoring
• Know the typical failure modes and how to determine most probable root cause and mitigation strategies
• Understand how the key attributes of a sterile product impact:
  • The pharmaceutical quality system
  • The organisation
  • The management oversight process
  • Risk management and mitigation
  • The end user or patient

We want you to learn, be engaged and have fun as well as take away practical knowledge that is immediately useful back in the workplace. Carefully designed case studies, teamwork tasks and problem-solving exercises (facilitated by highly experienced course tutors) ensure that you learn by doing.

Course Outline

• Regulatory Standards for Sterile Products
• Creating the Controlled Environment
• The Design, Validation, Operation and Maintenance of:
  • Cleanrooms
  • Isolators and restricted access barrier systems (RABS)
  • Sterile preparation and formulation
  • Steam
  • Water (from bore hole to water for injection)
• Aseptic and Terminal Sterilization (TS) Production Methods
• Environmental Monitoring (The What, Why and How)
• Routine Disinfection (A Quality Critical Activity)
• Critical Utilities
• Sterilization Processes: Everything You Need to Know
  • Moist heat (autoclaves)
  • Dry heat (ovens and tunnels)
  • Filtration
  • Irradiation
  • Vaporised hydrogen peroxide (VHP) surface sanitization
• Process Simulations (Media Fills): The What, Why, How and What If
  • Regulatory requirements
  • How to design media fills “fit for purpose”
  • Best industry practice
  • What to do when they fail
• Container Integrity and Particulate Inspection
  • How to validate and test
  • How to manage failures (from root cause investigation to corrective and preventive action (CAPA) implementation)
• People Issues
  • How to select, educate and manage cleanroom staff
  • Gowning and good aseptic practices
  • How to motivate, lead by example and understand, promote and enforce good aseptic behaviors
• Problem Solving and Troubleshooting (Dealing With the Unplanned)
  • What to do when things go wrong

Prerequisites

For any queries regarding entry requirements for both QP training and/or postgraduate qualifications please contact us

Additional information

NSF delivers instructor-led QP courses with blended training methods, in a mix of virtual and in-person courses. Please visit our website for current dates. If you cannot see your delivery method of choice, please contact us