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

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Category Food, Drugs & Biologics

Deadline: July 25, 2106 | Date: July 25, 2106

Venue/Country: Canada

Updated: 2016-06-30 18:44:50 (GMT+9)

Call For Papers - CFP

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