FDA’s New Requirements for Pyrogen & Endotoxin Testing for Drugs, Biologics & Medical Devices

Event Information
Product Format
Prerecorded Event
Dr. David Lim, Ph.D., RAC, ASQ-CQA
60 minutes
Product Description

Where Are You with FDA’s New Requirements for Pyrogens and Endotoxins Testing Programs?

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.

Session Highlights

  • Update on Applicable Laws and Regulations
  • Understand FDA's Recommendations in the Past
  • Discuss Common Misconception and Misinterpretation
  • Come to Terms With Current FDA Testing Requirements: Pyrogen and Endotoxins
  • Explain Requirements for Sampling, Storage, and Handling
  • Recognize Monocyte Activation Test (MAT): When and Why
  • Explain Rabbit Pyrogen Test: When and Why
  • Figure-out Limulus Amoebocyte Lysate (LAL) Test: When and Why
  • Understand Retesting Requirements
  • Distinguish Standards for Consideration
  • For see FDA Enforcement Actions
  • Figure-out PASS-IT Recommendations

Who should attend

  • Professionals in the healthcare industry: drugs, biologics, medical devices/IVDs, combination products, etc.
  • Regulatory Affairs Personnel
  • Clinical Affairs Personnel
  • Quality Assurance Personnel
  • Compliance Officers
  • Radiation Safety Officers
  • Laboratory Personnel
  • R&D Personnel

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About Our Speaker

Dr. David Lim - FDA Medical Device  Regulation Expert

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.

Dr. Lim has helped both pharma and medical device industry for regulatory, clinical and compliance...   More Info
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