A-Z of Sterile Products Manufacture
What you'll gain from this course
From aseptic practices to Z‑values, this course gives you a complete, practical grounding in sterile product manufacturing. Designed to be engaging and highly interactive, it helps professionals at all levels understand the scientific, technical and regulatory realities of GMP for sterile products. Whether your focus is EU, FDA or other global requirements, you’ll gain the insight, skills and confidence needed to meet today’s compliance expectations.
Parenteral products bypass the body’s natural defences, so any defect can cause serious harm. This course focuses on how product quality is assured through clear, practical review of the science and compliance principles behind sterile manufacturing.
Training is available virtually or in person. Virtual delivery combines instructor‑led sessions with self‑paced online learning. Full details will be provided after registration.
This course is approved by the Royal Society of Chemistry for continuing professional development and updated to reflect the latest revisions to EudraLex Volume 4, Annex 1.
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
- 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
- Vaporized 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 CAPA implementation)
- People Issues
- 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
Course Tutors
- Darren Jones – Former MHRA inspector specialising in sterile products; internationally recognised QA expert in auditing, GMP risk and patient‑focused decisions.
- Sheila Shadbolt – 15+ years across human and veterinary manufacturing (APIs, sterile, vaccines, biologics); strong global regulatory expertise from development to distribution.
- James Culyer – 20+ years in technical, quality and leadership roles; experience across multiple dosage forms with strong site quality and global supply chain expertise.
- Philip Rose – Former MHRA Lead Senior GMDP Inspector; extensive experience from QC to QP and senior roles, assessing complex international sites against EU GMP/GDP.
Discounts
Multiple delegate discounts are available on this course. Please contact us at [email protected] for further information. NHS staff will receive an automatic discount when registering with an NHS email address.
Learning Outcomes
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 organization
- 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.
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