Many manufacturers initially find the requirements of Annex 1 to be an impenetrable jungle of paragraphs and processes. We are your GPS guide through the regulations. Three professionals, one plan! Drawing on our practical experience, we will help you develop a GMP-compliant hygiene concept that is not just a tick-box exercise.
We will show you how to navigate your way through the wilderness using a concrete example, covering everything from risk analysis and the selection of suitable PPE, cleaning agents and disinfectants to revalidation, without getting bogged down in the swamp. Included in your expedition luggage are the critical interfaces between people, materials, and methods.
Join us on a journey through sterile production—with eye-opening moments, typical pitfalls, and lessons learned from three expert perspectives. Effective, implementable, and regulatory compliant.