GMP Annex 1: Changes in Microbial Monitoring
Episode 3Jan 15, 10:29 AM
[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
Dr Anne-Grit Klees, is a Global Product Manager for Environmental Monitoring at Merck KGaA, Darmstadt, Germany. She is a microbiologist and graduated at Philipps Universität Marburg in 1992. Since then she has been Global Product Manager for Biotest, heipha Dr Müller GmbH and Merck Life Science with strong expertise on environmental monitoring in pharmaceutical industries including ready-to-use culture media for air, surface and personnel monitoring.
Adèle Gisselmann is Global Product Manager for Environmental Monitoring at Merck KGaA, Darmstadt, Germany. She has three years of experience in technical support for process solutions at Merck KGaA, Darmstadt, Germany, and a background in the food and beverage industries and microbiology.