Cleanroom, Microbiology and Sterility Assurance Practices

This 2-day accredited training will provide attendees a comprehensive knowledge about the A-Z of Sterility Assurance which is based on regulatory requirements, FDA guidance, compliance expectations and industry practices. Key elements of sterility assurance and contamination control which starts from creating a robust and compliant cleanroom design, validation/qualification, operations, environmental monitoring program requirements, microbiological processes/methodology, cleanroom cleaning/disinfection, trafficking, gowning requirements and contamination control will be extensively discussed. Other key aspects of achieving product sterility such as a good understanding of the basics of sterilization processes–physical and chemical processes and the various examples of sterilization equipment and their specific process parameters will also be discussed. Critical regulations affecting Sterility Assurance requirements such as 21 CFR Part 211, ISO 14644 (various parts), ISO 11135, 11137, 11138, 14160, 14937, 17664, 17665, FDA Guidance for Industry and other regulations guiding these critical topics will be covered. Discussions will include the criticality of aseptic processing and other key contamination control evaluators during the manufacture and testing of products.