FDA New Requirements for Pyrogen and Endotoxin Testing for Drugs, Biologics and Medical Devices

This presentation is intended to discuss current FDA requirements for pyrogen and endotoxins testing required for drugs, biologics and medical devices for regulatory purposes. In particular, it is intended to discuss 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).

To obtain FDA approval or clearance for medical products, it is of paramount importance that firms accurately understand the requirements including common misinterpretation so that costly mistakes can be avoided.

This presentation will provide great opportunities for industry professionals to be better aware of and rather get more familiar with the current FDA testing requirements for drugs, biologics and medical devices concerning pyrogen and endotoxins testings.

The speaker will walk you through recent FDA requirements and common misconception for pyrogen and endotoxins testing for drugs, biologics and medical devices.

Areas Covered in the Session :
Applicable Laws and Regulations
Understand FDA’s Recommendations in the Past
Common Misconception and Misinterpretation
Current FDA Testing Requirements: Pyrogen and Endotoxins
Requirements for Sampling, Storage, and Handling
Monocyte Activation Test (MAT): When and Why
Rabbit Pyrogen Test: When and Why
Limulus Amoebocyte Lysate (LAL) Test: When and Why
Retesting Requirements
Standards for Consideration
FDA Enforcement Actions
Speaker’s PASS-IT Suggestions and Recommendations

Who Will Benefit:
Regulatory Affairs Departments
Clinical Affairs Departments
Quality Assurance Departments
Compliance Officers
Radiation Safety Officers
Laboratory Personnel
Research & Development Departments

Dr. David Lim

Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Doctor (www.RegulatoryDoctor.us). As a leading industry speaker, Dr. Lim frequently presents global regulatory and quality compliance topics in various forums and meetings. Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past eight years. Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009.

Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker. Dr. Lim leads and directs all research projects including pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor. Dr. Lim currently serves as a member of the Advisory Board for Inspection Insider published by FDA News.

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  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance