Recently the U.S. Food and Drug Administration (FDA) published its new endotoxin guidance document, which is an update to the existing 1987 Endotoxin Guideline. In order for firms to accurately understand the requirements to obtain FDA approvals and clearances for medical products, it is of paramount importance that common misinterpretations are eluded to, and costly mistakes are avoided.
This presentation by expert speaker Dr. David Lim, Ph.D., RAC, ASQ-CQA will discuss the latest FDA requirements for pyrogen and endotoxins testing required for drugs, biologics and medical devices for regulatory purposes. In particular, this session will review FDA’s testing recommendations and acceptance criteria for appropriate components and finished products to be tested in view of available standards to the industry (e.g., drugs, medical devices, and biological products).
David will provide great opportunities for industry professionals to be better aware of and become familiar with the current FDA testing requirements for drugs, biologics and medical devices concerning pyrogen and endotoxin testing. He will walk you through recent FDA requirements and common misconception for pyrogen and endotoxins testing for drugs, biologics and medical devices.
Who should attend
Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Consulting Firm, Regulatory Doctor (www.RegulatoryDoctor.us). As a leading industry speaker, Dr. Lim frequently presents various topics in areas of FDA regulatory, clinical, quality and regulatory compliance matters in various forums and meetings.