Utilizing alternative sterilization validation methods can not only save time and money when developing new medical devices, but they can also provide an excellent business continuity plan.
However, the U.S. Food and Drug Administration (FDA) has increased scrutiny on the use of newer, alternative sterilization methods (i.e. flexible chamber EtO) and lesser-known methods such as H2O2 and ClO2. This has proven to be challenging for several medical device manufacturers as they plan for regulatory submissions and approvals.
Join NAMSA, alongside a panel of medtech industry experts, for a virtual discussion focused on the use of alternative sterilization validation methods and strategies and best practices regarding how to mitigate risk of when employing these test methods in regulatory submissions.
Attendees can expect to gain a better understanding on:
- Novel sterilization methods and their key features and limitations
- How to evaluate the regulatory risks of using novel sterilization methods
- The availability and logistical implications of using on-site vs. off-site sterilization systems
Who Should Attend: Regulatory Professionals, R&D Professionals, VPs and Directors of Regulatory, Sterilization Managers and Quality Control Managers