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.
Beginners in ATMP manufacture or „classic-GMP” experts, who want to get introduced to ATMP-GMP.
Seminar language will be ENGLISH.
Rules & Rationals
Facilities, Equipment, Utilities
Qualification & Validation
DATE, TIME, VENUE
Available upon request.
Karl Metzger, gmPlan GmbH
690 Euro (plus VAT)