GMP Basics for ATMP

NOTE. Postponed to January 9, 2025

This training is an introduction to GMP requirements for both manufacturing of investigational ATMP and ATMP with a marketing authorisation.

Course description:

GMP is short for Good Manufacturing Practice and ATMP stands for Advanced Therapy Medicinal Products (medicines based on genes, cells or tissue engineering). This course will give you an introduction to GMP for ATMP, covering requirements for both manufacturing of investigational ATMP and ATMP after a market authorisation. You will get an overview of the EU requirements in EU GMP Part IV and an understanding of important elements of GMP.

Course outline 

• Introduction and background of GMP and quality systems
• Regulatory requirements and authorities
  • Introduction to EU GMP Part IV and other relevant regulatory requirements and guidelines for ATMP
  • Authorities and how they perform oversight
• Risk management and risk-based approach
  • Introduction to risk management and methodology
  • Risk-based approach for ATMP
• Knowledge management and continuous improvements
  • Introduction to change management, deviations and CAPA
• GMP Compliance
  • Overview of important parts of the requirements during manufacturing operations, with focus on the quality objectives
• Documentation requirements
  • Purpose of governing documents and records
  • Basic requirements on records – how to record data correctly
  • Data integrity
• Introduction to validation and qualification
  • Walk-through of concept and terminology for qualification of manufacturing equipment and validation of manufacturing processes
  • Differences in requirements for investigational ATMP and ATMP intended for the market

Learning objectives:

• Understand and define different terms used and being able to navigate in applicable regulatory texts and guidance from authorities
• Get additional knowledge in the GMP requirements for manufacturing of ATMP
• Be familiar with the most common terms and the general methodology for qualification and validation
• Be familiar with the basic requirements related to instructions and records, regardless of if they are in paper or electronic form to ensure data integrity

Who should attend:

• Newly employed or persons that shall start to work with investigational ATMP (intended for clinical studies) or ATMP on the market:
  • Employees within quality, production development, QC, and laboratory operations
  • Support functions, purchasing/logistics, technical and maintenance

Prerequisites:
None

#5152