Cleanroom, Microbiology and Sterility Assurance Practices

This 2-day accredited training addresses the various key elements of sterility assurance and contamination control such as cleanroom regulations, classification, sources and types of particles, design requirements, validation/qualification, operations, environmental monitoring program requirements, excursion investigations, data trending, microbiological processes/methodology, cleanroom cleaning/disinfection. The types of micro-organisms, typical mitigation steps in ensuring an effective contamination control through personnel training , gowning controls, cleanroom trafficking (entry and exit policy), contamination control, cleaning and disinfection program and the basics of sterilization processes–physical and chemical processes will also be discussed. The various regulatory bodies’ requirements such as 21 CFR Part 211, ISO 14644, FDA Guidance for Industry and others will be covered. Discussions will include the criticality of aseptic processing and other key contamination control evaluators during the manufacture and testing of products.