2016 - Webinar on FDA New Requirements for Pyrogen and Endotoxin Testing for Drugs, Biologics and Medical Devices

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
Consultants
Contractors/Subcontractors