Description
GMP and aseptic processing, Manufacturing techniques, Quality control, Risk management
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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.
Essentials of Cell and Gene Therapy GMP Manufacturing in Under 60 Minutes
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