The recent 2020 draft of EU GMP Annex 1, which regulates the manufacture, control and release of sterile pharmaceutical products in the EU, signals that there are comprehensive changes to come. This webinar will outline a holistic approach to ensure continued compliance, taking into account the expected changes, including the need for EM programs and procedures based on risk analysis.
If you operate aseptic manufacturing areas or facilities, such as ISO 5 cleanrooms in a traditional set up, RABS or isolators, you should watch this on-demand webinar.
Key Learning Objectives:
- The persons to involve in preparing the EM program and workflow and their roles within risk management
- How recent trends in manufacturing sterile products will impact your EM
- Managing your data and data analysis as well as the data cycle to allow you trending and predictive workflows
Speakers
Dr. Anne-Grit Klees
Merck
Global Product Manager Environmental Monitoring
Dr. Anne-Grit Klees is a Global Product Manager Environmental Monitoring at Merck. She is a microbiologist who received her PhD from the University of Marburg in 1992. After working at Pall as a medical officer, she moved on to become a global product manager at Biotest AG, heipha Dr. Müller GmbH and Merck KGaA, Darmstadt, Germany. She has gained considerable expertise in environmental monitoring in the pharmaceutical industry, in particular with ready-to-use culture media and microbial air samplers for air, surface, and personnel monitoring.
Aram Montazami
BEng, Vice President of R&D – Cofounder
Novatek International
With 20 years of experience developing products for regulated and healthcare industries, Aram has successfully co-founded Novatek International, Novatek Medical Data Systems, Cognistat and Cognistat Sport. Aram plays an active role in the management of the Novatek Engineering Team as well as the R&D activities with a 100 percent success rate over the last 15 years. With a background in Electrical and Computer Engineering and added expertise in regulated (GAMP, GxP, etc) and niche market product development, Aram has successfully managed the development and implementation of over 18 software products ranging from thick client-server to Saas solutions to clients worldwide.
Microbiological testing
- Sterility testing
期間:36min
言語:English
セッション 1:presented December 18, 2022
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