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

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Website https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=FDB1768 | Edit Freely

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

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


Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
Disclaimer: ourGlocal is an open academical resource system, which anyone can edit or update. Usually, journal information updated by us, journal managers or others. So the information is old or wrong now. Specially, impact factor is changing every year. Even it was correct when updated, it may have been changed now. So please go to Thomson Reuters to confirm latest value about Journal impact factor.