The presentation will establish the requirements to bid and provide services in the highly regulated life sciences manufacturing facilities. From the regulatory framework of FDA, Europe, Japan, China and Brazil regarding cleaning manufacturing facilities to understanding the Scope of Work for clean areas and documentation requirements. I can provide specific incidences where cleaning is mentioned in Warning Letters and the cost of these observations to the customers. Training of staff will be extensively discussed as well as type of audits that should be performed. A good overview and tools for any company that wants to get in to this very profitable niche.