European Aseptic Technologies & Annex 1 Conference
8/9 April 2025, Wiesbaden, Germany
Course No. 21843
Objectives
Reasons to attend this conference:
You will be informed on new regulatory and technological developments in aseptic / sterile manufacturing
You learn how current GMP and production requirements have to be implemented technologically in sterile manufacture
Pain points will address issues that are difficult to put into practice in the Industry
You will get case studies from pharmaceutical companies
Background
The revised EU GMP Guideline Annex 1 was published in August 2022 after extensive discussion and came into force mainly in August 2023. Among other things, the consequences of this revised Annex 1 will be presented and discussed with inspectors and industry representatives. The discussion on Annex 1 will be complemented by case studies from pharmaceutical companies on new technological developments in the pharmaceutical production environment.
Target Group
The event is directed at specialists and managers from the pharmaceutical industry as well as at engineers and planners who have to deal with European Annex 1 and current aseptic technologies in clean areas in their daily practice.
Fill & Finish of various Ready-to-Use Containers from clinical late Stage until commercial Launch of Biologicals through to high-potent Products Stylianos Sampanis, Sanofi-Aventis Deutschland Ralf Wagner, Optima pharma
Accelerating Pharmaceutical Manufacturing: A Case Study of entering Syringe and Cartridge Fill-Finish Production Henning Austermann, Siegfried Hameln Klaus Ullherr, Syntegon Technology
H2O2 Ingress Study Approach for Isolator Decontamination of the AT-Vials Dr Maria Loos, Johnson and Johnson Adrian Keller, SKAN
Container Closure Integrity Test Luigi Scaffidi, Boehringer Ingelheim Pharma
Pain Points with Annex 1
Quality Risk Management in Aseptic Manufacturing: Reasonable Use Dr Ingrid Walther, ECA Working Group on Annex 1
Sterile Filtration – PUPSIT and Requirements beyond Dr Frank Sielaff, Regional GMP Authority Darmstadt, Germany
Practical Application of setting up an annual Contamination Control Strategy (CCS) Assessment Ruben van der Galiën, GE HealthCare Dr Prachi Sawant Raschdorf, GE HealthCare
RTU Horst Koller, HK Packaging Consulting Katharina Golly, Novartis Pharma
“RTU + RTS Materials – GMP Requirements for the Pharmaceutical Manufacturer and Supplier Qualification” Dr Rainer Kahlich, Local GMP Authority of Baden-Württemberg, Germany
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Testimonials
Seminar Programme as PDF