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Documents Compliance with the FDA Guidances on Investigator Responsibilities and the Form 1572

1. Compliance with the FDAGuidances on Investigator Responsibilities and the Form 1572Presented byPaul Below, CCRA, CCRTP. Below Consulting, Inc. 2. About the Speaker•…

Documents Medical Device Reporting and Tracking Rod Perez, M.S.E. Consumer Safety Officer Division of Small...

Slide 1Medical Device Reporting and Tracking Rod Perez, M.S.E. Consumer Safety Officer Division of Small Manufacturers, International and Consumer Assistance Western Canada…

Business FDA Audit - The Do and Don't List

1. Do’s and Don’tsDuring An FDA InspectionCopyrighted 2013 Compliance Insight, Inc. 2. When dealing with the FDA investigator,we should demonstrate knowledge of andconfidence…

Documents Clinical Trial Data Integrity: Bioresearch Monitoring Program Jur Strobos MD JD FACEP Olsson Frank.....

Slide 1 Clinical Trial Data Integrity: Bioresearch Monitoring Program Jur Strobos MD JD FACEP Olsson Frank Weeda Terman Matz [email protected] 240-472-9665 Slide 2 BiMo…

Documents Out of Specification Results (OOS) A One Day Workshop

Out of Specification Results (OOS) A One Day Workshop Presented by: Karen S. Ginsbury PCI Pharmaceutical Consulting Israel Ltd. For IFF March 2007 Purpose of Workshop Understand…

Documents mycotoxins

Mycotoxins What are they? Where do they occur? What do they do? Who makes them? What is risk to food supply? Important mycotoxins Aflatoxin Ergot alkaloids Trichothecenes…