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
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
Radiation Safety Officers
Research & Development Departments