This intensive ON DEMAND 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.
Upon completion of this course, you will be able to:
You will be redirected to our secure system.
This training will benefit those involved in the manufacturing, processing, testing, and release of sterile and non-sterile products within various industries such as Pharmaceuticals, Biotechnology, Drug, Biologics, Medical Device, Compounding Pharmacies, Cell Therapy, and In-vitro Diagnostics Product Manufacturing. It will be especially beneficial to personnel and management in:
When you need on-site attention, we’re not just here to help, we’re there to help—right by your side.
Individual courses are remarkably effective. But sometimes when you have a specific need, it helps to have expert guidance right in the room with you and your team.
In that case, we’re happy to design a custom training for your entire team, whether online—or on-site.Learn more
We’ve rebranded! CfPA is now COBBLESTONE