Extractables and Leachables Virtual Summit 2020
About
Date/Time
Date(s) - July 30, 2020 - July 31, 2020Join NAMSA for the Extractables and Leachables Virtual Summit on July 30-31. Throughout this two-day, virtual conference, industry experts will examine the safety, quality and regulatory issues central to the medical device and biotech industries—including the keys to satisfying recent revisions to several applicable USP chapters and the recently revised standards contained in ISO 10993.
NAMSA Educational Session: Commercial Implications of a Properly Planned Biological Evaluation Strategy, Including the Use of Chemical Characterization
Presented by: Lisa M. Olson, MBA; Vice President, North American Laboratory and Global Analytical Services, NAMSA
Date/Time: Friday, July 31 | 11:05-11:45 AM ET
Since 2009, the emphasis on a risk management process and characterization of materials continues to shift the biological safety paradigm. Put simply, the days of medical product manufacturers merely contracting with a testing laboratory to perform a handful of biological safety tests is no longer an accepted practice by any global regulatory body. Medical device regulators now require carefully planned evaluation strategies based on risk and empirical data. Join this session to learn how a well-planned strategy utilizing chemical characterization can have favorable outcomes, including cost saving implications, for the commercialization of your medical device product. Discussed will be:
- A step-by-step instruction on when to start your planning
- What steps to follow to execute chemical characterization testing and/or biological testing
- How to keep your timelines as short as possible
Agenda
Since 2009, the emphasis on a risk management process and characterization of materials continues to shift the biological safety paradigm. Put simply, the days of medical product manufacturers merely contracting with a testing laboratory to perform a handful of biological safety tests is no longer an accepted practice by any global regulatory body. Medical device regulators now require carefully planned evaluation strategies based on risk and empirical data. Join this session to learn how a well-planned strategy utilizing chemical characterization can have favorable outcomes, including cost saving implications, for the commercialization of your medical device product. Discussed will be:
Speaker
Lisa Olson, MBA
Vice President, North American Laboratory and Global Analytical ServicesLisa has nearly 25 years’ medical device industry experience, including laboratory operations, research and development, service development, market development and executive leadership, as well as international standards development. She brings a multifaceted view to strategic growth and organizational transformation within highly regulated businesses. Lisa received her undergraduate degree in Microbiology from the University of Minnesota and her Masters of Business Administration from the University of St. Thomas.