European Aseptic Technologies – Annex 1 Conference

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

Registration

Register as a congress delegate for just 690 EUR/day!
This special offer is only valid until 31 December 2024!

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 Audience

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.

Detailed Programme

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 GmbH

Accelerating Pharmaceutical Manufacturing: A Case Study of entering Syringe and Fartridge 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, Pharma Consulting Walther

Sterile Filtration – PUPSIT and Requirements beyond
Dr Frank Sielaff, Regional Authority Darmstadt

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 Tübingen

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