Date/TimeMay 20, 2021
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
Kirk HonourPrincipal Consultant - Product Development Strategy
Kirk Honour has been involved in the MedTech industry for more than 25 years, bringing products from concept to commercialization. He is the Founder of YapStone Inc. and Co-Founder EVO Transportation & Energy Services.
Ted MayPresident & CEO, Andersen Products, Inc.
Ted May has more than 20 years of experience in the field of infection control, and more than 35 years of experience in international business and trade promotion—both with private companies and at the Federal and State levels.
Nicole WilliamsDirector of Commercialization, Sterilucent, Inc.
Nicole Williams has more than 22 years of experience in the medical device industry, ranging from low temperature sterilization, medical device development and clinical and regulatory affairs.
Paul LorcheimDirector of Operations, ClorDiSys Solutions
Paul Lorcheim has been a part of the pharmaceutical industry for more than 40 years. He has been with ClorDiSys Solutions, Inc. since 2001 as Director of Operations directing the implementation, commercialization and manufacturing of various decontaminating and sterilization equipment for the pharmaceutical, life science and food industry.