Helpful information sources will be discussed along with requirements device companies omit when they enter the combination product arena. Finally, the session will provide information on deciding on strategies for combination product stability testing and understanding the stability risk.
Understanding best practices for combination product package stability and validation
Hear Synthes USA’s Packaging Validation Supervisor Laure L. Larkin explain FDA governing documents as well as the ISO counterparts.
Apr 28, 2011
At the May 26 Healthcare Packaging Conference & Workshops event in Princeton, NJ, Laure L. Larkin will cover how our stability world is changing, especially as it relates to combination products. Larkin, the packaging validation supervisor for Synthes, will address how stability testing relates to the new global economy its many combination product stakeholders. Attendees will learn the U.S. FDA governing documents as well as the ISO (Intl. Organization for Standardization) counterparts.
Synthes is a leading international medical device company, specializing in the development, manufacturing, and marketing of instruments and implants. Larkin brings more than 20 years of experience in FDA-regulated industries, and has worked with both larger Fortune 100 companies and smaller entrepreneurial organizations. She has functional experience in validation activities related to stability, packaging, cleaning, equipment, software, and test methods, as well as general compliance and risk management.