Course description
Aseptic GMP for Cell & Gene Therapies
New to Cell and Gene Therapy manufacturing?
Manage a team of technicians that work in clean rooms?
Gain the skills and knowledge of aseptic GMP to ensure you fully understand the clean room requirements for the manufacturing of Cell or Gene Therapies. Over three modules, you will become familiar with the aseptic GMP requirements which must be adopted for the manufacture of these advanced medicinal products. Learn best practices for gowning, environmental monitoring and cleaning to ensure the efficient and compliant production of your product.
Do you work at this organisation and want to update this page?
Is there out-of-date information about your organisation or courses published here? Fill out this form to get in touch with us.
Upcoming start dates
Suitability - Who should attend?
This course will be directly applicable to people who will be 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
Outcome / Qualification etc.
- Understand why the manufacture of Cell & Gene Therapy Products require stringent aseptic GMP standards
- Learn key clean room operational procedures, including: gowning, cleaning and environmental monitoring
- Explore aseptic GMP conditions throughout the product lifecycle
- Understand the difference between working as a clean room performer and verifier
Training Course Content
- Module 1: Introduction
- Module 2: General Considerations in Clean Room
- Module 3: Practical Issues in Aseptic Work of Production Employees
Why choose PTI
On average, delegates of their online academies said:
Quality of content:
4/5
85% had applied content during the course to their role
Delivery rating:
4/5