Good Manufacturing Practice Workshop

Update/Important information
Nov. 19, 2019
A new edition of the GMP Workshop is currently being organized. Please signify your interest by registering 
using the form below (no payment required until spots confirmed and invoice issued) and be the first informed of the next edition's dates!

Introduction

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. 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. 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

  • 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

When? Where?

Next location and date to be determined. 

Why shouldn't you miss it? 

  • Access Canada’s largest active GMP cell manufacturing facility
  • Network with world-class experts on GMP cell manufacturing
  • 100% of 2018 participants said the workshop met or exceeded their expectations
  • 100% of 2018 participants would recommend this workshop

Preliminary Workshop Agenda

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
  • Typical progression of projects

Day Three – 8:00 – 16:00, Tuesday

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

  • Cell production
  • Quality Control
  • Debriefing and questions

Registration process & Registration Fees

Space in this workshop is limited so don't waste time! Complete the application form below by October 25, 2019, 5:00pm Eastern Standard Time.

Please note you will receive the invoice once your application had been approved by CellCAN. 

Registration fees for this workshop are as follow: 

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

Travel awards

Travel awards will be announced soon.

Event sponsorship available

Please contact Marie-Eve Desormeaux at me.desormeaux@cellcan.com

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 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.

Questions:

For further information on this workshop please contact Craig Hasilo c.hasilo@cellcan.com. For application related inquires, please contact Vanessa Laflamme at vlaflamme@cellcan.com

 

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