Understanding the New FDA Draft Guidance for Chemical Characterization
About
Date/Time
Date(s) - October 9, 202410:00 AM - 11:00 AM CT
The FDA’s highly anticipated new draft guidance on chemical characterization represents a great opportunity for the industry to understand the FDA’s expectations for chemical characterization. Our expert speakers will break down the key aspects of this guidance, providing you with the knowledge and tools needed to navigate these changes effectively. Additionally, NAMSA experts will discuss the need to submit comments to the FDA for their review.
Key Takeaways
- Understanding the New Requirements: Gain a comprehensive overview of the new FDA guidance and its implications for your organization.
- Best Practices for Compliance: Learn practical strategies to ensure your chemical characterization processes meet the new standards.
- Q&A Session: Get your questions answered by industry experts. Don’t miss this opportunity to stay informed and ensure your organization is prepared for the new regulatory landscape. Register now to secure your spot!
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Speaker
Angela Sanchez
Associate Scientific DirectorAngela Sanchez is the Associate Scientific Director at NAMSA. Her work focuses on chemical characterization of medical devices. She specifically leads regulatory compliance of ISO 10993-18 analyses. Angela received her Bachelors of Science at Wayne State University and went on to graduate school at Colorado State University. She has over 20 years of chemistry experience. Previously, she has worked as a synthetic organic chemist in the field of RNA interference for greater than 10 years. She has also served as a Technical Director and Senior Scientist in leading CROs.
Cayla Ruch, PhD, DABT
ToxicologistDr. Ruch is a Board Certified Toxicologist with over 6 years of experience in the medical device industry. She was previously a Study Director responsible for conducting safety and efficacy preclinical studies and studies in compliance with the ISO 10993 standards, and a Project Manager for the Biological Safety Team.
Dr. Ruch received her PhD in Nutritional Biochemistry from the University of Minnesota – Twin Cities, with a research focus on high-fat diet-induced cognitive decline. In 2023, she received her Diplomate of the American Board of Toxicology (DABT) certification. Dr. Ruch is an active member of the Society of Toxicology.
Kallol Biswas, PhD
Associate Vice President Global Analytical Services and Scientific DirectorDr. Biswas is the Associate Vice President and Scientific Director for Global Analytical Services at NAMSA, with nearly 22 years of experience in the pharmaceutical and medical device industries. He holds a Ph.D. in Chemistry from The Florida State University and B.A. and M.S. degrees from West Virginia University. Dr. Biswas began his career at Eli Lilly and Company, later transitioning to the FDA, WIL Research Labs, and Charles River Laboratories. He has been actively involved with the American Association of Pharmaceutical Scientists (AAPS) and has contributed significantly to various scientific and educational initiatives.