Interpretation of Recent Developments in FDA Guidance for Chemical Characterization

Learn more about the FDA chemical characterization draft guidance and chemicals list for analytical performance (CLAP). The draft guidance clarifies Part 18 chemical characterization including extraction, identification of analytes, and method suitability. The CLAP affects determining uncertainty factors, key experimental parameters for determining analytical evaluation thresholds. Understanding these changes will be essential in successful future studies. Understand the context of FDA draft guidance and the CLAP Review major points of clarification in the draft guidance Understand potential impact of changes on the chemical characterization process Need help with a medical device project? Learn more about Medical Device testing services at EAG Laboratories: https://www.eag.com/brochures/medical... Find more webinars at https://www.eag.com/webinar/ For your testing needs, contact us at https://www.eag.com/contact/