Webinar on FDA New Requirements for Pyrogen and Endotoxin Testing for Drugs, Biologics and Medical Devices
Website https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=FDB1768 |
Category Food, Drugs & Biologics
Deadline: July 25, 2106 | Date: July 25, 2106
Updated: 2016-06-30 18:44:50 (GMT+9)
Call For Papers - CFPThis 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 RegulationsUnderstand FDA’s Recommendations in the PastCommon Misconception and MisinterpretationCurrent FDA Testing Requirements: Pyrogen and EndotoxinsRequirements for Sampling, Storage, and HandlingMonocyte Activation Test (MAT): When and WhyRabbit Pyrogen Test: When and WhyLimulus Amoebocyte Lysate (LAL) Test: When and WhyRetesting RequirementsStandards for ConsiderationFDA Enforcement ActionsSpeaker's PASS-IT Suggestions and RecommendationsWho Will Benefit:Regulatory Affairs DepartmentsClinical Affairs DepartmentsQuality Assurance DepartmentsCompliance OfficersRadiation Safety OfficersLaboratory PersonnelResearch & Development DepartmentsConsultantsContractors/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.