Course Information

Course Information

• The course begins at the time stated at the top of the page
• The course is broken up into modules outlined below
• There will be breaks between modules

Session 1

TBD | 180 mins | 9:30 AM UK

Overview of the regulations that govern cell & gene therapies

• What products are we talking about?
• Introduction to the relevant guidelines applicable to ATMPs in Europe and the US

Examine facilities, equipment, utilities

• Examine facility design required for cell & gene therapies
• Review the aseptic GMP processes specific to ATMPs
• Discuss cleanroom controls to achieve a relevant Sterility Assurance Level
• Quality Management
• Examine documentation & personnel
• Outsourced activities

Production of cell & gene therapies

• Up-stream process
• Down-stream process
• Packaging and labelling

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.

Session 2

TBD | 180 mins | 1:30 PM UK

Quality control techniques for ATMPs

• Discuss sampling
• What testing is required for release

Examine qualification & validation

• Calibration
• Qualification
• Validation

Other specialised topics related to cell & gene therapies

• Batch release
• Automated production
• Blood products
• Good Tissue Practice (GTP)

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.