A-Z of Sterile Products Manufacture Training

Dates

Times

5 days

Location

In-Person - Manchester, United Kingdom

Availability

About This Course

From Aseptic practices to Z values and everything in between!

For over 30 years we have hosted this highly participative and popular sterile products manufacturing training course. Thousands of pharmaceutical industry professionals around the world have benefitted from learning about key scientific, technical and regulatory challenges associated with Good Manufacturing Practice (GMP) of sterile products manufacturing. 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. Linking everything you do to providing a safe and effective formulation to the end user is critical. 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.

This course is offered either virtually, or in-person at a hotel venue. If you choose our virtual learning option, training will be delivered via a combination of an instructor-led virtual classroom and self-paced learning online. Full details will be sent to you following registration.

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

This course has been revised in line with the revisions to EudraLex Volume 4, Annex 1.

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 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.

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 corrective and preventive action (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

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.

Sheila Shadbolt – Sheila is an experienced quality professional with over 15 years’ experience in pharmaceutical manufacturing environments in both human and veterinary products within small molecule API, sterile products, vaccines and biological product manufacture. She has extensive knowledge of worldwide regulatory agency expectations for medicinal product development, manufacture, and distribution.

James Culyer – James has over 20 years’ experience in technical, quality and managerial roles within parenteral, non-sterile liquid, oral solid dosage and inhalation product manufacture. He has extensive experience managing all aspects of manufacturing site quality management systems and is a specialist in global supply chain assurance activities.

Philip Rose – Philip Rose has over 20 years of experience in a wide range of roles within the pharmaceutical industry, from QC through to senior management and as a Qualified Person. Most recently, he worked as a Lead Senior GMDP Inspector for the UK competent authority, the MHRA. Within this role, he inspected some of the most complex cases globally against EU GMP and GDP in areas such as biologicals (including vaccines), steriles, non-steriles, ATMPs and specials.

Ian Harwood – Ian is a GMP Consultant with over 20 years’ industry experience, including extensive knowledge of Pharmaceutical Quality Systems and GMP for steriles, biotech, IMPs, radiopharmaceuticals and unlicenced medicines. He spent 8 years as a GMP Inspector with the MHRA and is eligible to act as a Qualified Person.

Discounts

Multi-delegate discounts available. Discounts also offered to NHS staff and charities.

  • Really educational course. Good dynamic between lecture and teamwork. Not just a read through of guidelines but a proper insight to what GMP is. The course has changed my mindset on manufacturing of sterile products.
    Maria Thestrup Kristensen
    Novo Nordisk, Denmark
  • The numerous practical examples from the previous experience of the tutors when they were inspectors were priceless. Another great NSF training course! I have done a number of NSF courses and have found them all to be excellent.
    Paul O'Shea
    Servier Laboratories PTY, Australia
  • The trainers are real professionals. You get a really good and valuable overview of sterile manufacturing. A course which is definitely worth it!
    Saskia Spahn
    Hoffman-La Roche, Switzerland