About This Course

From air change rates to Z values and everything in between!

For over 30 years we have hosted this highly participative and popular four-and-a-half-day sterile products training course. Thousands of pharmaceutical industry professionals around the world have benefitted from learning about key scientific, technical and regulatory challenges associated with the Good Manufacturing Practice (GMP) of sterile products manufacturing. You too can understand how to implement an effective, compliant quality system that assures the safety and quality of products. Whether you need to meet EU, FDA or any other regulatory agency’s needs, this course gives you the knowledge, skills and tools to succeed.

A pharma product administered parenterally bypasses the body’s natural defense mechanisms. Consequently, any quality defect could potentially cause serious harm to the end user. Manufacturers cannot afford to overlook key quality, sterile product attributes or parts of their pharmaceutical quality system (PQS) that identify and mitigate risk. Our manufacturing sterile products training course concentrates on how product quality is assured via practical and interactive review of the science and compliance behind sterile products manufacturing.

Linking everything you do to providing a safe and effective formulation to the end user is critical. Using case studies, models and practical exercises, we help you make that connection.

This course is approved by the Royal Society of Chemistry as suitable for its members’ continuing professional development.

Key Learning Objectives

Completion of this sterile products training course helps you understand:

  • The how and why of common sterile production methods
  • How to identify and tackle key quality risks
  • How to perform focused GMP audits of sterile facilities

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.

We also provide “exhibits” (e.g. pumps, valves, filters, biological indicators, vessels and model cleanrooms) for you to handle, discuss and interpret.

We help you see, evaluate and act on the common production and quality control (QC) concerns in sterile formulation.

Updated Session

We’ve updated the course to include insight into the latest draft of EudraLex Volume 4 Annex 1 and how it affects your facility design, aseptic process and the training of your staff.

Course Outline

Regulatory Standards for Sterile Products

  • What they are
  • How to interpret them
  • Regulatory hot topics: Present and future

Creating the Controlled Environment

The design, validation, operation and maintenance of:

  • Cleanrooms
  • Isolators, restricted access barrier systems (RABS) and bowl-fill-seal (BFS)
  • Sterile preparation and formulation
  • Aseptic and terminal sterilization (TS) production methods
  • Environmental monitoring (the what, why and how)
  • Routine disinfection (a quality critical activity)

Critical Utilities

The design, validation, operation and maintenance of:

  • Steam
  • Water (from bore hole to water for injection)

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 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

Course Tutors

Course tutors will be selected from the following:

Darren Jones - With extensive operational QA experience including being an MHRA inspector specializing in sterile products, Darren is an internationally recognized expert in his field. His unique insight is indelibly linked to how to audit in a way that provides accurate identification of GMP deficiencies and proportionate assessment of product, patient and GMP risk.

Eric Dewhurst - Eric has spent 40 years working in the manufacture and control of sterile pharmaceuticals and medical devices. He has extensive experience in microbiology, sterilization technology, aseptic processing, quality assurance and validation. He has published a number of texts on aseptic processing and sterilization methods, and is also involved in the preparation of ISO standards in this area.

Christof Langer - Christof has vast experience along the entire supply chain of pharmaceutical operations of APIs and FDPs manufacturing including chemicals and biologics. He has been directly responsible for parenteral drug dosage manufacturing for more than 20 years. As well as his master’s degrees in biotechnology and business administration, he has broad knowledge in pharmaceutical quality systems and is an IRCA-certified pharmaceutical auditor. Christof is also a trained Lean Six Sigma Black Belt and a certified Quality Risk Manager.

Pauline Johnstoner - Pauline has a degree in medical microbiology and 30 years’ experiences in industry. She became a Qualified Person under the permanent provisions in 2013 and currently supports the ATMP and biologicals arena in both commercial and clinical trial settings. She has fulfilled a number of roles in the pharmaceutical sector including QC, QA and validation.