Understanding Aseptic GMP for Cell and Gene Therapies

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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 to 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.

 

What is included?
  • Direct access to an expert trainer
  • Interactive and engaging sessions with exercises and discussions
  • Access to the Educo Life Sciences Training Portal
  • Unlimited access to the recordings for 2 weeks after the session

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
Course Outline

Course Information

  • The course begins at the time stated at the top of the page
  • The course is broken up into modules outlined below
  • There will be breaks between modules
Module 1

Introduction to aseptic GMP in CGT

  • What are Cell & Gene Therapies and how they differ from traditional biotech and pharma
  • Typical manufacturing considerations: auto, allo and timelines with infusion back to patient
  • Why we need clean rooms?
  • Understanding aseptic work in a cell and gene environment?
Module 2

General considerations in a clean room

  • Review and analyse GMP considerations throughout the whole product Lifecyle
  • Examine clean room processes including:
    • Gowning
    • Environmental monitoring
    • Flow
    • Cleaning
  • Documentation principles
Module 3

Aseptic GMP and production personnel

  • Understand the necessary behaviour and practice required in clean rooms
  • What is the role of individual employees in the clean rooms
  • Golden rules for aseptic techniques
  • What are the roles when working in the clean room and what are the responsibilities of each one of them
  • How to consider air flow direction when working in the hood
  • How to clean items before putting them in the hood

TBC

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

 

Could your team benefit from this course?

We can customise this course to meet the requirements of your organisation, delivered as a classroom and/or online course.

For more information you can email us at [email protected] or call +44 (0) 203 111 7357.

Or please summarise your objectives by completing the form below.

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• This course is delivered online
• For live online courses, module durations are approximate
• You will have full access to the training portal and the recordings for a week after the training