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GMP for ATMPs (Cell and Gene Therapies)
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GMP for ATMPs (Cell and Gene Therapies)

Register Your Interest

Identify, understand and apply GMP guidelines to your ATMP to ensure compliance

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 entering clinical trials and gaining full market approval is rising year on year. The ATMP industry continues to receive significant investment as successful therapies appear to treat, and sometimes cure, devastating illnesses. Due to the complex nature of cell and gene therapies the GMP requirements are significantly different to small and large molecules. Quality leaders must be competent in GMP for ATMPs, knowing how to identify and apply the guidelines relevant to their product.

 

This course provides a complete overview of the GMP guidelines relevant to cell and gene therapy products. Upon registration you will be asked to complete a pre-course form so the course expert can modify the content to support your product needs. Once completed you will have a fundamental understanding of the GMP requirements in Europe and the US.

Key Learning Objectives

 

  • Define and understand the basics of cell and gene therapies.
  • Examine the GMP requirements for manufacturing of investigational ATMPs and fully approved ATMPs.
  • Review and understand the GMP guidelines for cell & gene therapies in the US (FDA) and Europe (EMA).
  • Discuss key elements of the GMP guide relevant to cell & gene products such as Annex 1 (sterile products) Annex 2 (biological materials) and Annex 14 Blood Products are all applicable.
  • Discuss the ATMP GMP guide and the differences between the regular requirements.
  • Become aware of GMP principles applicable to cell and gene therapy products.

What is Included in a Short Live Online Course?

 

  • Direct access to an expert trainer
  • Interactive and engaging sessions
  • Access to the Educo Life Sciences Training Portal
  • Unlimited access to the recordings for 2 weeks after the session

Course Dates

 

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

13 November 2024

1-Day Live Online Training
Register at the top of the page.

13 May 2025

1-Day Live Online Training
Register at the top of the page.

7 October 2025

1-Day 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.

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 online.
  • 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)

Learn more about the course by toggling through the tabs below (trainer, venue, who should attend?)

Course Information

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
Session 1

TBD | 180 mins | 9:30 AM UK

Overview of the regulations that govern cell & gene therapies

  • What products are we talking about?
  • Introduction to the relevant guidelines applicable to ATMPs in Europe and the US

Examine facilities, equipment, utilities

  • Examine facility design required for cell & gene therapies
  • Review the aseptic GMP processes specific to ATMPs
  • Discuss cleanroom controls to achieve a relevant Sterility Assurance Level
  • Quality Management
  • Examine documentation & personnel
  • Outsourced activities

Production of cell & gene therapies

  • Up-stream process
  • Down-stream process
  • Packaging and labelling

Practical exercises, group work and case studies

Interactive group exercises in the form of discussion and/or exercises are also included as part of the course to cement your knowledge.

Session 2

TBD | 180 mins | 1:30 PM UK

Quality control techniques for ATMPs

  • Discuss sampling
  • What testing is required for release

Examine qualification & validation

  • Calibration
  • Qualification
  • Validation

Other specialised topics related to cell & gene therapies

  • Batch release
  • Automated production
  • Blood products
  • Good Tissue Practice (GTP)

Practical exercises, group work and case studies

Interactive group exercises in the form of discussion and/or exercises are also included as part of the course to cement your knowledge.

Rob Walker, Director, Rob Walker GMP Consultancy, Ltd. is a chartered chemist and a fellow of the Royal Society of Chemistry with degrees in applied chemistry and instrumental analytical chemistry.

 

He has more than 30 years of experience in the pharmaceutical industry including 25 years as a qualified person. After 16 years in senior management at CP Pharmaceuticals, the last seven as quality director, he is now a director of his own GMP consultancy company.

 

Rob has comprehensive GMP manufacturing and quality experience covering a wide range of dosage forms and, has successfully managed GMP inspections by MHRA and FDA.

 

Rob has extensive experience delivering presentations to industry forums including ISPE, the Parenteral Society and PDA in both the EU and the US. Rob delivers training globally, supporting both established and upcoming organisations develop GMP processes, practices and behaviours. More recently, Rob has delivered GMP training in the complex and growing area of ATMPs as professionals increasingly move to ATMP manufacturing.

The course is designed for professionals involved in the manufacturer of cell and gene therapies or ATMPs. It is designed for those new to GMP and for those need to understand GMP for cell & gene therapies.

 

It is ideal for those working in big biopharma, medical schools/universities, hospitals and clinical centres and even regulators. It is perfect for those in:

  • Quality Assurance
  • Quality Control
  • Quality Validation
  • Regulatory affairs
  • CMC Regulatory Affairs
  • Technicians
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