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Good Manufacturing Practice Workshop

Introduction

The Stem Cell Network is happy to support the third edition of the Good Manufacturing Practice (GMP) Workshop offered by CellCAN in partnership with C3i, by once again providing financial support to the SCN community to attend this workshop. 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 working under GMP conditions and the requirements for GMP manipulations are regulated and 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 training in which participants will actually perform manipulations according to GMP standards. In addition, attendees will have the opportunity to experience the workflow in a GMP facility and learn how a GMP cell therapy facility is organized. The ongoing regulatory review and what to expect will also be presented and discussed.

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.

Workshop Learning Objectives

  • Health Canada Food & Drug Regulations: 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 – cleanrooms, 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

Workshop Dates: November 17-19, 2019
Workshop Location
: Centre d’Excellence en Therapie Cellulaire (CETC) at Hôpital Maisonneuve-Rosemont, 5415 L’Assomption Boulevard, Montreal, H1T 2M4

Preliminary Workshop Agenda:
Day One
13:00 – 16:00, Sunday November 17

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

Day Two
8:00 -16:00, Monday November 18

  • 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 November 19
Hands-on course. Participants will be working in groups of three.

  • Cell production
  • Quality Control
  • Debriefing and questions

Application Procedure & Registration Fees
Space in this workshop is limited; all those interested in participating must submit an application to attend the Good Manufacturing Practice workshop to CellCAN via this website form.

Registration fees for this workshop are as follows:

  • Canadian Academic Centres:                $850
  • Canadian Non-Academic Centres:        $1,250
  • International Participants:                      $1,800

Financial Support Available

The Stem Cell Network is offering a limited number of awards to enable eligible candidates to attend this Good Manufacturing Practice workshop. All those interested in receiving financial support for this event must submit a financial support application to SCN after registering as an attendee with CellCAN to secure a spot (note that no payment is required at the moment of online registration).

Details of the SCN Award and Application Procedure:

This SCN award provides financial assistance for trainees to attend the Good Manufacturing Practice workshop, November 17-19, 2019, organized by CellCAN in partnership with C3i at the Centre d’Excellence en Therapie Cellulaire (CETC) in Montreal.

Application Deadline: Wednesday, October 9, 2019

Conditions:

  • Application deadline is 11:59 PM (sender’s time) Wednesday, October 9, 2019.
  • The SCN award 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) and 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 award will also cover the workshop registration fee (paid directly to the organizers).

Eligibility for the SCN Award:

  • 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 demonstrate that they will apply the techniques learned at the workshop to their own research project.

Application Procedure:

  1. Secure a spot for the workshop by completing the registration form on CellCAN’s website.
  2. Complete the financial support application form and return it, along with any additional documents required, by email to rcadwalader@stemcellnetwork.ca by 11:59 PM (sender’s time) Wednesday, October 9, 2019.
  3. The SCN Training & Education Committee will review all complete applications, and applicants will be informed of the competition outcome by Wednesday, October 23, 2019.

 Reporting and Communication 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’s 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 Craig Hasilo at c.hasilo@cellcan.com

For inquiries related to signing-up for the workshop, please contact Vanessa Laflamme at vlaflamme@cellcan.com

For all SCN financial support-related inquiries, please contact Rebecca Cadwalader at rcadwalader@stemcellnetwork.ca

 

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