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Patricia S. Kerby, MPA Office of Human Subjects Protection January 7, 2009 How to Survive an FDA Inspection.
Documents Patricia S. Kerby, MPA Office of Human Subjects Protection January 7, 2009 How to Survive an FDA...

Slide 1Patricia S. Kerby, MPA Office of Human Subjects Protection January 7, 2009 How to Survive an FDA Inspection Slide 2 Why are Inspections Done? Protect the rights and…

Site Inspections: Are You Ready?
Business Site Inspections: Are You Ready?

1. Site Inspections: Are You Ready? 2. Who performs site inspections? • Sponsor/CRO CRA or monitor, regulatory affairs, QA • Pre-Study visit • Site initiation visit…

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HPLC METHODS FOR PHARMACEUTICAL ANALYSIS George Lunn and Norman R. Schmuff A WILEY-INTERSCIENCE PUBLICATION JOHN WILEY & SONS, INC. New York / Chichester / Weinheim /…

Preparing for a Clinical Research Monitoring Visit: Guidance for an FDA Audit, Sponsor/CRO Monitoring Visit, and more...
Education Preparing for a Clinical Research Monitoring Visit: Guidance for an FDA Audit, Sponsor/CRO...

Marlene Berro, MS, RAC Special Projects Office of Ethics and Compliance ClinicalTrials.gov Campus Administrator CTSI Regulatory Consultant January 10, 2012 Guidance for an…

What Does FDA Consider During a Food Facility Inspection? How will FSMA Change This? FDLI Enforcement, Compliance, and Litigation Conference December 9,
Documents What Does FDA Consider During a Food Facility Inspection? How will FSMA Change This? FDLI...

Slide 1 What Does FDA Consider During a Food Facility Inspection? How will FSMA Change This? FDLI Enforcement, Compliance, and Litigation Conference December 9, 2014 Miriam…

How to Survive an FDA Inspection
Documents How to Survive an FDA Inspection

Patricia S. Kerby, MPA Office of Human Subjects Protection January 7, 2009 How to Survive an FDA Inspection Why are Inspections Done? Protect the rights and welfare of human…

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