Timestamps
[1:20] - Key Changes in Annex I
[2:31] - Rapid and Alternative Methods in Annex I
[6:10] - Qualification of Recovery Rates for Air Samplers & Culture Media
[7:45] - Validating Media for its Neutralization Efficiency
[9:05] - Validating Air Samplers
[14:40] - New Sections in Annex I (Aseptic Process Simulation/Media-fill etc.)
[20:28] - How Merck KGaA, Darmstadt, Germany can help with Regulatory Requirements
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.
Adèle Gisselmann
Merck
Global Product Manager Environmental Monitoring
Adèle is the Global Product Manager for Environmental Monitoring, after 3 years in Technical Support at Merck (Process Solutions) and a background in the Food and Beverage industry and microbiology.
Microbiological testing
- Microbial culture media preparation
Duration:24min
語言:English
會話 1:提出 May 31, 2021
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