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Understanding Aseptic GMP for Cell and Gene Therapies
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Understanding Aseptic GMP for Cell and Gene Therapies

Register Your Interest

This course is currently not scheduled however it can be delivered for your team. To register your interest, complete the form below

Register Your Interest

 

Register your interest in the course. When we schedule dates, we will be in touch.

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Learn more about the course by toggling through the tabs below. Scroll down to view the agenda, trainer info and who should attend.

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

What is Included in a Live Online Course?

 

  • Direct access to an expert trainer.
  • Interactive and engaging sessions with exercises and discussions.
  • Bitesize learning.
  • Access to the Educo Life Sciences Training Portal.
  • Unlimited access to the recordings for 4 to 5 weeks after the last session.
  • A reinforcement session delivered 4 to 5 weeks after the course (online) providing you with extra time with the trainer.
  • A validated certificate of attendance is available for you to download.

Course Dates

 

Find out when this course is running so you can plan your training. Scroll down to view the full agenda.

Dates TBC

1 Week Live Online Training
Register at the top of the page.

Group Discount

 

If you want to train a small group, we offer a group discount between 5% and 50% depending on the course and number of attendees.

 

For a quote, complete our contact form by following the link. Get in touch.

Customised Team Training

 

We also design and deliver fully customised team training focused on your products, processes, technologies and challenges. This is ideal for specific training requirements or larger groups. Please get in touch with us for more information.

 

For more information, complete our contact form by following the link. Get in touch.

Free Online Module

 

  • Module 1 is free to attend and delivered online at a date 3 to 8 weeks before the full course start date.
  • To register for module 1, please submit your details in the form located in the agenda.
  • Module 1 is recorded so if you are unable to attend, you can catch up ahead of the course start date.

 

Full Course Information and Pricing

 

  • To attend the full course, you must register online at the top of the page by selecting the course dates from the drop-down and clicking enrol to add the course to your basket. Once added, please follow the checkout instructions to pay via credit card or bank transfer.
  • There are price tiers for this course. The dates of these are located above. The earlier you register the more you save.
  • The full training course is delivered either online or in a classroom. Please check which course format you have booked.
  • For hybrid training – In the event we do not have enough people on one of the options we will contact you to discuss switching.
  • For live online courses – The dates and times of modules/sessions are subject to change.
  • For live online courses – The module/session durations are approximate.

 

Frequently Asked Questions (FAQs)

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

 

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