With no relief in sight for supply chain issues and sterilization constraints, understanding the options associated with change has become an immediate need in industry. This 3-day webinar will identify considerations and challenges outlined in regulatory standards to allow for success in an agile environment. Our topics of focus include navigating Ethylene Oxide & Radiation Sterilization, Packaging, and Biocompatibility/Biosafety changes and addressing the expectations around managing changes.
Day 1: Ethylene Oxide & Radiation Sterilization: Evaluating the Impact of a Change
Abstract: The presentation will cover some case studies addressing the current challenges in a consistently evolving regulation environment. Both environmental considerations and product safety will be covered. Additionally, it will also cover the unavailability of components and material shortages that can lead to lengthy delays or require a revision of the product to continue production. Those revisions require careful consideration with regards to product bioburden terminal sterilization or potential sterilization residues. This presentation will review case studies to provide insight into handling your product or sterilization parameters change.
- How do component or material changes affect product bioburden?
- How to evaluate changes to the product or process
- How changing materials, suppliers, or processes can affect bioburden and sterilization.
- How Ethylene oxide reduction program can address the lower and challenging residues limits while not compromising the sterility assurance level.
