GMP for ATMPs

Advanced Therapy Medicinal Products (ATMPs), such as cell and gene therapy, present unique challenges in terms of quality, production, and traceability. In this one-day training course, you will learn how GMP principles are applied within an ATMP environment and what specific risks and points of attention play a role in this. The training combines regulations with practical examples, enabling you to better translate GMP requirements to your own organization and processes.

This training might be subject to change.

The training is intended for professionals who work with ATMPs and are involved in production, quality control, or quality assurance within pharmaceutical, biotech, or hospital pharmacies.

The training covers the following topics, among others:

• introduction to ATMPs and GMP
• differences between traditional GMP and ATMP production
• facilities, cleanrooms, and aseptic working
• documentation, batch records, and traceability
• deviation management, change control, and CAPA
• roles of QA, QC, and QP within ATMP processes
• practical examples and cases from the ATMP environment

After this training, you will have:

• greater insight into GMP requirements for ATMPs
• better control over quality and compliance risks
• a better understanding of how regulations are translated into practice in the workplace
• greater confidence in preparing for inspections and audits
• concrete tools for better embedding GMP within ATMP processes