Annex 1 Intensive Training Course - Live Online Training
3/4 July 2024
Course No. 21176
Speakers
Dr. Bettina Rietz-Wolf
Regierungspräsidium Tübingen
Dr. Rainer Gnibl
GMP Inspektor, Regierung von Oberbayern
Dr. Ingrid Walther
Pharma Consulting Walther
Arjan Langen
GE Healthcare
Robert G. Schwarz
GXP-TrainCon
Carsten Moschner
CMC3
Dr. Daniel Müller
GMP Inspector
Dr. Philip Hörsch
Vetter Pharma-Fertigung
Matthias Schaar
Novartis
Dr. Jürgen Blattner
BSR
Stephan Löw
CSL Behring
All times mentioned are CEST.
Objectives
This Live Online Training offers you a unique opportunity to familiarize yourself with the new regulatory requirements of the revised final Annex 1, the impact on aseptic manufacturing, terminal sterilization and the challenges related to quality aspects. Still need to implement some points and need suggestions? Or you would like to review your approach and compare it with the experience of colleagues and inspectors?
Speakers from the authorities as well as representatives from the pharmaceutical industry and experts from technical suppliers will present their views and experiences in areas such as quality risk management, process simulation, as well as the challenging topics PUPSIT and CCIT. In addition, the much-discussed topic of contamination control strategy will be addressed and solutions presented.
The classic topics of contamination control such as environmental monitoring, cleaning and disinfection, personnel hygiene will also be discussed with you.
Background
The aseptic filling of a sterile product must be performed in a controlled environment. (Grade A clean room in a corresponding classified environment). The most relevant part of the EU GMP Guide for this type of production is Annex 1 of this Guide. After a long revision period of the previously valid 2008 version and two rounds of comments, the long-awaited revised Annex 1 for the manufacture of sterile medicinal products was finally published by the European Commission on August 25, 2022. The main reason for the update was to reflect changes in the regulatory environment and new developments in manufacturing technologies, which include a significant shift towards the application of quality risk management principles. The new Annex 1 is into force since August 25, 2023.
Target Group
This Live Online Training is of interest to professionals from
Pharmaceutical and biopharmaceutical manufacturers,
Authorities and suppliers with responsibilities in Aseptic Manufacturing,
Quality Assurance,
Quality Control,
Auditing,
Inspections
who are involved in
Contamination Control,
Engineering,
Monitoring,
Qualification and Validation,
Internal Audits,
Quality Affairs,
Aseptic Process Simulation/Media Fill
Technical Requirements
We use WebEx for our live online training courses and webinars. At https://www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our trainings and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.
Testimonials
Seminar Programme as PDF