Good Manufacturing Practice Workshop

The Stem Cell Network is pleased to offer a brand new workshop on good manufacturing practice (GMP) to its community. The number of GMP facilities is growing in Canada with the rapid progressions in cell therapy. This has created a need for well trained personnel as GMP conditions and the requirements for GMP manipulations are quite different from those in standard research laboratories. In this workshop attendees will learn the essentials of GMP requirements from experts, illustrated by several experiences from actual clinical trials. The workshop will be a mixture of lectures and hands-on experience in which participants will actually perform manipulations according to GMP standards. Moreover, attendees will have the opportunity to experience the workflow in a GMP facility and learn how a GMP cell therapy facility is organized.

Who Should Attend?
This workshop on Good Manufacturing Practice is designed for cell biologists (and other end users) who want to advance their knowledge on moving cell therapies towards the clinic or are working, or plan to work, in areas associated with cell therapies.

Workshop Learning Objectives

  • International Harmonization guidelines, HC guidelines: Safety of Human Cells, Tissues and Organs for Transplantation Regulations (CTO Regulations)
  • Foundation for the Accreditation of Cellular Therapy (FACT)
  • ISO levels and measurement requirements – airflow
  • Organizational set-up – clean rooms, product and waste flow, shipment
  • Training of personnel on protocols
  • SOPs, Batch Records
  • Product certificate of analysis, release criteria and documentation
  • Single- versus multi-site requirements
  • Minimally manipulated versus more than minimally manipulated cells
  • Project Progression

Workshop Dates: June 11, 12 and 13, 2017
Workshop Location: Centre d’Excellence en Therapie Cellulaire (CETC) at Hospital Maisonneuve-Rosemont, Montreal

 

Workshop Agenda

Day 1 – Sunday June 11, 1:00 PM – 4:00 PM

  • Introduction to the GMP facility
    • Requirements, standards of clean rooms
    • Visit of the facility

Day 2 –Monday June 12, 8:00 AM – 4:00 PM

  • Equipment required to maintain GMP standards
  • Regulation regarding cell therapy projects
  • Examples of cell therapy projects at the CETC
  • Typical progression of projects

Day 3 –  Tuesday June 13, 8:00 AM – 4:00 PM
Hands-on course. Participants will be working in groups of 3

  • Cell production
    • Cell culture transfers
    • Automated Ficoll cell separation
    • Cryopreservation
    • Evaluation
  • Quality Control
    • Flow cytometry
    • Progenitor Assay
    • Sterility analysis using BacTalert
  • Debriefing and questions


Application Deadline: Wednesday, April 26, 2017

Download the Workshop and Bursary Application Form here

 


Application procedure and registration fees:

Space in this workshop is limited; therefore, all those interested in participating must submit an application to attend the Good Manufacturing Practice workshop by Wednesday, April 26, 2017.

Selected applicants will be notified by Friday, May 12, 2017, and will be instructed on how to proceed with registration for the workshop.

The registration fee for this workshop is $1,200.


Eligibility and Financial Support Available
The Stem Cell Network is offering a limited number of awards to enable eligible candidates to attend this workshop on Good Manufacturing Practice Workshop, June 11-13, 2017, organized by Dr. Denis-Claude Roy at the CETC in Montreal. All those who submit an application to attend will automatically be considered for sponsorship and travel bursaries through the appropriate network.

Download the Workshop and Bursary Application Form here

 


Details of the SCN bursary:

Conditions:

  • Application deadline is 11:59pm (sender’s time) Wednesday, April 26, 2017.
  • The SCN bursary will cover travel expenses associated with attending the workshop, for trainees not based in Montreal:
    • Travel to/from the workshop location
    • Up to three nights shared accommodation at our designated hotel (day 1, day 2, and day 3)
    • Meals not provided during the workshop
  • Reimbursement will be processed following the workshop and in accordance with the SCN Travel Booking & Reimbursement Policy (policy will be provided to the selected applicants).
  • Accommodation during the course will be provided for trainees not based in Montreal.  Two participants of the same gender may be required to share a room.
  • The SCN bursary will also cover the workshop registration fee of $1,200 (paid directly to the organizers).


Eligibility for the SCN Bursary: 

  • Applicants must be a highly qualified personnel (HQP – i.e. a graduate student, post-doctoral fellow, research assistant or research associate) working in a Canadian lab.
  • Applicants must be working on a research project related to stem cells or cell therapy.
  • Applicants must clearly indicate how the techniques and knowledge learned at the course apply to their own research project.

Application Procedure:

  1. Complete the application form and return it, along with any additional documents required, by email to rcadwalader@stemcellnetwork.ca by 11:59pm (sender’s time) Wednesday, April 26, 2017.
  2. The SCN Training & Education Committee will review all complete applications, and applicants will be informed of the competition outcome by Friday, May 12, 2017.

 


Reporting and communications requirements:

By accepting a SCN award, the recipient agrees to provide a report describing the value of the training and networking opportunities made available through the award. This information will be used at SCN discretion on its website, newsletters and for the purpose of reporting to their funding agencies. By registering for this workshop attendees also consent to have their pictures taken during workshop and used in reporting tools as mentioned above. Please note that expense reimbursement will be processed only once the completed report is received.

 


Questions:

For further information regarding the content of this workshop please contact Janetta Bijl at jbijl@stemcellnetwork.ca.

For application related inquiries, please contact Rebecca Cadwalader at rcadwalader@stemcellnetwork.ca