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.
Completion of this sterile products training course will enable you to:
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.
The design, validation, operation and maintenance of:
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.
Multi-delegate discounts available. Discounts also offered to NHS staff and charities.
Designed to provide aspiring QPs and pharma quality professionals with the knowledge they need to be able to assess microbiological risks.
Understand EU and FDA requirements for design, execution, assessment and reporting of equipment qualification and process validation studies.
Get tools and techniques designed to improve your decision-making skills and better protect your company and the patient.