Hands-on GMP workshop: APPLY NOW (only 9 spots)
In partnership with
The number of good manufacturing practice (GMP) facilities is growing in Canada with the rapid progressions in cell therapy. This has created a need for well-trained highly qualified personnel (HQP), as working under GMP conditions and requirements for GMP manipulations are regulated and quite different than in standard research laboratories. In this course the attendees will learn the essentials of GMP requirements from experts illustrated by several experiences from actual clinical trials. The workshop is a mixture of lectures and hands-on training. Participants will actually perform manipulations according to the GMP standards. Moreover, attendees will have the chance to experience the workflow in a GMP facility and learn how a GMP cell therapy facility is organized.
Workshop Dates: October 14-15-16, 2018
Workshop Location: Centre d’Excellence en Thérapie Cellulaire (CETC) at Maisonneuve-Rosemont Hospital, Montreal
Who Should Attend
This workshop on Good Manufacturing Practice is designed for cell biologists, technologists, research scientists, process engineers and trainees (and other end users) who are working or plan to work in areas associated with the manufacturing of cell therapies, or want to expand their knowledge on advancing cell therapy projects towards the clinic. The outcome from this unique workshop will be the transfer of advanced knowledge creating a foundation of GMP-based know-how for the next generation of HQP.
Workshop Learning Objectives
- Safety of Human Cells, Tissues and Organs for Transplantation Regulations (CTO Regulations) and associated standards
- Health Canada Food & Drug Regulations: Part C Drugs, Div. 1, Div. 1A Establishment Licence, Div. 2 Good Manufacturing Practices, Div. 4 Schedule D Drugs (Biologics), Div. 5 Drugs for Clinical Trials Involving Human Subjects
- International Harmonization guidelines
- Foundation for the Accreditation of Cellular Therapy (FACT)
- ISO levels and measurement requirements – airflow
- Organizational set-up – clean rooms, product and waste flow, shipment (cold chain transport)
- Training of personnel on protocols
- Standard Operating Procedures (SOP) & Batch Records
- Product certificate of analysis, release criteria and documentation
- Data and sample storage
- Single- versus multi-site requirements
- Minimally manipulated versus more than minimally manipulated cells
- Project Progression
Day One – 13:00 – 16:00, Sunday
- Introduction to the GMP facility
- Requirements, standards of clean rooms
- Visit of the facility
Day Two – 8:00 -16:00, Monday
- Equipment required to maintain GMP standards
- Regulations regarding cell therapy projects
- Training of personnel
- Defining release criteria
- Examples of cell therapy projects at the CETC
- Typical progression of projects
Day Three – 8:00 – 16:00, Tuesday
Hands-on course. Participants will be working in groups of three.
- Cell production
- Cell culture transfers
- Automated Ficoll cell separation (Sepax)
- Evaluation and sterility testing
- Quality Control
- Flow cytometry
- Sterility analysis using BacTalert
- Debriefing and questions
Application Procedure & Registration Fees
Application Deadline: September 14, 2018 - 5pm EST (see form below)
Space in this workshop is limited; therefore, all those interested in participating must submit an application to attend the Good Manufacturing Practice workshop.
Selected applicants will be notified by September 21, 2018 and will be instructed on how to proceed with registration for the workshop.
The registration fees for this workshop are
- Academic Centers: $800
- Non-Academic Centers: $1,200
Reporting and Communication Requirements
By submitting an application for this workshop, the participant agrees to fill out a report describing the value of the training and networking opportunities made available through the workshop, as well as generate feedback on how this workshop has impacted their work or career path in the months following the training. This information will be used at C3i and CellCAN’s discretion on their websites, newsletters and for the purpose of reporting to their funding agencies. By registering for this workshop, attendees also accept to have their pictures taken during workshop and used in reporting tools as mentioned above.
For further information on this workshop please contact Craig Hasilo firstname.lastname@example.org. For application related inquires, please contact Vanessa Laflamme at email@example.com.