Essentials of Cell and Gene Therapy GMP Manufacturing in Under 60 Minutes

This course is designed for cell biologists, research scientists, process engineers, trainees (and other end users) who want to have a basic understanding of what cell and gene therapy manufacturing under GMP means.

Learning objectives:

• Explain how production under GMP differs from routine laboratory work, including process development;
• Identify the main components of Quality Management Systems (QMS) required to manufacture biotherapeutics under GMP;
• Describe the critical path and steps to translate process development into GMP production: minimizing risk.

Modules:

1. Introduction
2. GMP and Canadian Regulations
3. A Look Inside GMP Facilities, Part 1
4. A Look Inside GMP Facilities, Part 2
5. Quality Management Systems (QMS)
6. Let's Recap

Completing this course will take you less than 60 minutes and will provide you with a certificate of completion after passing the exam.