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Documents Structured Data Capture (SDC) Overview for HL7 Clinical Quality Information WG Evelyn Gallego, MBA,....

Slide 1 Structured Data Capture (SDC) Overview for HL7 Clinical Quality Information WG Evelyn Gallego, MBA, CPHIMS Office of Science & Technology (OST) Office of National…

Documents CBER Blood Establishment Registration and Product Listing Jan O’Brien Blood Registration...

Slide 1 CBER Blood Establishment Registration and Product Listing Jan O’Brien Blood Registration Coordinator DBA, OBRR, CBER September 15, 2009 Slide 2 CBER 2 Outline What…

Documents The Top 10 List – Best Lessons Learned from FDA Warning Letters Walter Nowocin Medtronic,...

Slide 1 The Top 10 List – Best Lessons Learned from FDA Warning Letters Walter Nowocin Medtronic, Inc./Minneapolis, Minnesota Measurement Science Conference 23 March, 2012…

Documents RESPONSIBILITIES OF INVESTIGATOR PRESENTED BY: Ms. GAYATRI P. Ms. GARGI VASHISHTHA Dr. YOGITA KADAM....

INVESTIGATOR RESPONSIBILITIES OF INVESTIGATOR PRESENTED BY: Ms. GAYATRI P. Ms. GARGI VASHISHTHA Dr. YOGITA KADAM Dr. VINAY BADGUJAR 1 CONTENTS INTRODUCTION SELECTION INVESTIGATOR…

Documents Welcome The University of Texas at Arlington Office of Research Integrity and Compliance Human...

Welcome The University of Texas at Arlington Office of Research Integrity and Compliance Human Research Protections Program (HRPP) Tier II Training Responsible Conduct in…

Documents New IRB Guideline Changes and Converting to eIRB - Suggestions for Maintaining Compliance. Ramesh...

New IRB Guideline Changes and Converting to eIRB -   Suggestions for Maintaining Compliance.  Ramesh Ghodgaonkar, BPHARM, MSITS, MSB, MBA Betsy Johnson, BA Frederick…

Documents HCT/P Compliance Update 6th Annual FDA and the Changing Paradigm for HCT/P Regulation Orlando, FL,.....

HCT/P Compliance Update 6th Annual FDA and the Changing Paradigm for HCT/P Regulation Orlando, FL, February 3-5, 2010 Mary Malarkey, Director, OCBQ, CBER Summary Inspections…

Documents Structured Data Capture (SDC) Public Health Tiger Team Call will begin 3 min after the hour November...

Slide 1 Structured Data Capture (SDC) Public Health Tiger Team Call will begin 3 min after the hour November 12, 2013 1 1 DRAFT: Not for distribution Public Health Tiger…

Documents AFDO Educational Conference: FDA Quality Initiatives

AFDO Educational Conference: FDA Quality Initiatives Ricky Rodriguez, Director FDA Dallas District Office Steve Silverman, Director CDRH Office of Compliance June 25, 2014…

Documents New IRB Guideline Changes and Converting to eIRB -   Suggestions for Maintaining Compliance. 

New IRB Guideline Changes and Converting to eIRB -   Suggestions for Maintaining Compliance.  Ramesh Ghodgaonkar, BPHARM, MSITS, MSB, MBA Betsy Johnson, BA Frederick…