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

Description :

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).

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