Identify, understand and apply GMP guidelines to your ATMP to ensure compliance
No scheduled dates for this course right now — but we can deliver it exclusively for your team.
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Course Information
TBD | 180 mins | 9:30 AM UK
Overview of the regulations that govern cell & gene therapies
Examine facilities, equipment, utilities
Production of cell & gene therapies
Practical exercises, group work and case studies
Interactive group exercises in the form of discussion and/or exercises are also included as part of the course to cement your knowledge.
TBD | 180 mins | 1:30 PM UK
Quality control techniques for ATMPs
Examine qualification & validation
Other specialised topics related to cell & gene therapies
Practical exercises, group work and case studies
Interactive group exercises in the form of discussion and/or exercises are also included as part of the course to cement your knowledge.
Rob Walker, Director, Rob Walker GMP Consultancy, Ltd. is a chartered chemist and a fellow of the Royal Society of Chemistry with degrees in applied chemistry and instrumental analytical chemistry.
He has more than 30 years of experience in the pharmaceutical industry including 25 years as a qualified person. After 16 years in senior management at CP Pharmaceuticals, the last seven as quality director, he is now a director of his own GMP consultancy company.
Rob has comprehensive GMP manufacturing and quality experience covering a wide range of dosage forms and, has successfully managed GMP inspections by MHRA and FDA.
Rob has extensive experience delivering presentations to industry forums including ISPE, the Parenteral Society and PDA in both the EU and the US. Rob delivers training globally, supporting both established and upcoming organisations develop GMP processes, practices and behaviours. More recently, Rob has delivered GMP training in the complex and growing area of ATMPs as professionals increasingly move to ATMP manufacturing.
The number of cell and gene therapies entering clinical trials and gaining full market approval is rising year on year. The ATMP industry continues to receive significant investment as successful therapies appear to treat, and sometimes cure, devastating illnesses. Due to the complex nature of cell and gene therapies the GMP requirements are significantly different to small and large molecules. Quality leaders must be competent in GMP for ATMPs, knowing how to identify and apply the guidelines relevant to their product.
This course provides a complete overview of the GMP guidelines relevant to cell and gene therapy products. Upon registration you will be asked to complete a pre-course form so the course expert can modify the content to support your product needs. Once completed you will have a fundamental understanding of the GMP requirements in Europe and the US.
The course is designed for professionals involved in the manufacturer of cell and gene therapies or ATMPs. It is designed for those new to GMP and for those need to understand GMP for cell & gene therapies.
It is ideal for those working in big biopharma, medical schools/universities, hospitals and clinical centres and even regulators. It is perfect for those in:
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