Detailed Description:
The environment for pharmaceutical production has changed massively over the last few years. A clear trend towards digitalization and automation is observable. New regulatory requirements have been set for GMP-compliant aseptic manufacturing to minimize contamination risks in cleanrooms. In this webinar we will give an introduction to the portable new MAS-100 Sirius® Microbial Air Sampler, which meets the new challenges. We will demonstrate how it supports regulatory compliance in a digital environment, minimizes handling errors and makes active air monitoring easier to perform. Another key focus will be the validation process – highlighting what GAMP 5-based development is all about and how validation on customer side is supported.
In this webinar, you will learn:
- How the MAS-100 Sirius® supports regulatory compliance in a digital environment.
- Strategies to minimize handling errors and enhance active air monitoring
- Insights into the validation process for effective implementation
Speakers
Corina Keller - Product Manager, MBV AG
Corina Keller holds a master’s degree in biochemistry from the University of Zurich and an MBA from the Lucerne University of Applied Sciences and Arts. She has been working in product management for over seven years, focusing on translating customer needs into well-aligned product portfolio strategies. She is responsible for the portfolio of portable microbial air samplers and works closely with interdisciplinary teams to develop effective solutions for microbial air monitoring in pharmaceutical cleanrooms.
Dr. Anne-Grit Klees - Global Product Manager, Merck KGaA, Darmstadt, Germany
Dr. Anne-Grit Klees is responsible for Innovation & Product Life Cycle Management with regard to microbial air samplers and media for aseptic process simulation for pharma cleanrooms and isolators. With a professional background in microbiology, she has been working in product and marketing management within the health industry for 30 years.
