Course Overview

The number of cell and gene therapies continues to grow. Consequently, more professionals are moving into the sector to meet this growing demand. These professionals must be aware of the aseptic manufacturing requirements and processes in place which differ considerably from biotech and small molecules.

This course will provide you or your team with the skills and knowledge to work in an aseptic GMP environment. You will understand the clean room requirements for the manufacture of Cell or Gene Therapies. Once completed, you will become familiar with the aseptic GMP requirements which must be adopted for the manufacture of advanced medicinal products. Learn best practices for gowning, environmental monitoring and cleaning to ensure the efficient and compliant production of your product.

Key Learning Objectives

• Understand why the manufacture of Cell & Gene Therapy Products require stringent aseptic GMP standards
• Explore aseptic GMP conditions throughout the product lifecycle
• Examine key clean room operational procedures, including: gowning, cleaning and environmental monitoring
• Understand the difference between working as a clean room performer and verifier
  

This course will be directly applicable to professionals working in cell and gene development and manufacturing. Specifically it is for those working in Cell and Gene Therapy clean rooms. These people will be responsible for clean room operations and in some instances, those directly involved in Cell & Gene Therapy manufacture. Some relevant departments may include:

• Clean room operations
• Quality
• Regulatory Affairs
• Cell Therapy processing
• Gene Therapy processing
• GMP
• Filling
• Cleaning