Remember – at checkout you can choose to take this course On-demand. We offer a 10% group discount when you register 2 of more attendees (up to 10). Contact us for larger groups.

This intensive, 12- Hour course provides 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 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.

Can’t Make the LIVE Course dates?

You can register now for the on demand! Simply select the On Demand option when registering and we will automatically send you access to the recorded version for you to view for 30 days. On Demand will be available within 2 weeks after the live offering.

PLEASE NOTE:Since this training is highly interactive, you must have a webcam on your computer equipped with a microphone and speakers/headset in order to fully participate.