GMP for ATMP (Advanced Therapy Medicinal Products)

Learn how to navigate through the GMP challenges involved with these innovative products

The guidelines on “Good Manufacturing Practice (GMP) specific to Advanced Therapy Medicinal Products (ATMPs)“ was adopted by the European Commission in November 2017 and became effective in May 2018. But what are ATMPs? How do they differ from other drugs? What are the regulatory requirements for ATMPs? And how do ATMP-GMP rules differ from those for active substances and medicinal products?
gmPlan GmbH offers you a suitable opportunity to get introduced to these topics in a full-day basic seminar (introductory course). You will learn to interpret the rules of good manufacturing practice and requirements in a meaningful way, to comply with them and to apply them in practice.

TARGET GROUP
Beginners in ATMP manufacture or „classic-GMP” experts, who want to get introduced to ATMP-GMP.

SEMINAR LANGUAGE
Seminar language will be ENGLISH.

CONTENT
Rules & Rationals

• The Rules Governing Medicinal Products in the European Union
• EU-GMP for ATMP
• Risk-based approach

Systems

• Quality Management
• Documentation
• Personnel
• Outsourced activities
• Defects

Facilities, Equipment, Utilities

• Facilities
• Equipment
• Utilities

Production

• Mantainance of seed lots and cell banks
• Up-stream Process
• Down-stream Process
• Packaging and Labelling

Quality Control

• Sampling
• Testing
• Stability

Qualification & Validation

• Calibration
• Qualification
• Validation

Specific Topics

• Batch Release
• Reconstitution
• Automated Production

DATE, TIME, VENUE
Available upon request.

SPEAKER
Karl Metzger, gmPlan GmbH

FEE
690 Euro (plus VAT)