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GMP Annex 1: Changes in Microbial Monitoring

Podcast

Stay Compliant

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 for Environmental Monitoring

Dr. Anne-Grit Klees, is a Global Product Manager for Environmental Monitoring at Merck. 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 with strong expertise on environmental monitoring in pharmaceutical industries, including ready-to-use culture media for air, surface, and personnel monitoring.

Adèle Gisselmann

Merck

Global Product Manager for Environmental Monitoring

Adèle Gisselmann is Global Product Manager for Environmental Monitoring at Merck. She has three years of experience in technical support for process solutions at Merck and a background in the food and beverage industries and microbiology

Podcast Information

Microbiological testing

  • Microbial culture media preparation
  • Language:English