'Fda regulations' diaporamas de présentation

Bacterial Testing of Platelet Components: 2008 Update

Bacterial Testing of Platelet Components: 2008 Update. William B. Lockwood, PhD, MD Clinical Professor Department of Pathology & Laboratory Medicine University of Louisville Director, Transfusion Services & Tissue/Bone Bank University of Louisville Hospital

900 views • 57 slides

FDA Foreign Priorities, Inspections and Compliance

FDA Foreign Priorities, Inspections and Compliance. Bruce Ross , M.A. M.P.H. Director, India Office. Agenda. Priorities Challenges of globalization cGMP deficiencies Comparison Post inspection regulatory actions.

893 views • 55 slides

FDA-Mandated Alternative to Bisphenol-A

FDA-Mandated Alternative to Bisphenol-A. Kristina Lenn Kevin Miles Gregory Jackett Isaac Norton August 5, 2010. Foreshadow. Introduction Effects of BPA on Human Physiology Possible Alternative Plastics to BPA Manufacturing Analysis Conclusion/Recommendation Questions. Introduction.

639 views • 46 slides

723 views • 44 slides

STVHCS Human Research Protection Program

STVHCS Human Research Protection Program. Kimberly Summers, PharmD Assistant Chief for Clinical Research South Texas Veterans Health Care System Research & Development Service. Human Research Protection Program (HRPP).

641 views • 44 slides

Human Research Protection Program 101

Human Research Protection Program 101. March 19-20, 2007 Cincinnati, Ohio. The Drug Side of FDA Regulations, with a Few Mechanics. C. Karen Jeans, MSN, CCRN COACH Project Analyst. What This Talk Will Cover. The mystique of the Investigational New Drug Application (IND) IND Emergency IND

1.44k views • 39 slides

Ethical Principles in Clinical Research

Ethical Principles in Clinical Research. Christine Grady Department of Clinical Bioethics National Institutes of Health. Moral problem in clinical research. The goal of clinical research is generation of useful knowledge about human health and illness

2.35k views • 36 slides

Having a Prosperous New Year with a CRO: The Gift of A Great Contract

Having a Prosperous New Year with a CRO: The Gift of A Great Contract. Paul G. Nardulli, Attorney At Law, Optima Law Group Claudia Shojai, Supply Chain Supervisor, INOVA Diagnostic Moderator: Tim Scott, President, Pharmatek. CRO Industry.

431 views • 34 slides

Suing the Federal Government

487 views • 30 slides

Genetically Modified Animals and Drug Production An EMPACTS Project for Biology 1544 Northwest Arkansas Community Colleg

Genetically Modified Animals and Drug Production An EMPACTS Project for Biology 1544 Northwest Arkansas Community College Melissa Mathison Meredith Reynolds Magdalena Carranza Chantel Litton Amy Saferite. Purpose of EMPACTS Projects.

556 views • 30 slides

Genetically Modified Animals and Drug Production An EMPACTS Project for Biology 1544 Northwest Arkansas Community Colleg

Genetically Modified Animals and Drug Production An EMPACTS Project for Biology 1544 Northwest Arkansas Community College Melissa Mathison Meredith Reynolds Magdalena Carranza Chantel Litton Amy Saferite. Purpose of EMPACTS Projects.

408 views • 30 slides

Informed Consent for Registries and Genetic Research

Informed Consent for Registries and Genetic Research Laura Carey Miller, MSHA IRB Manager Inova Health System Institutional Review Board Laura.Miller@inova.org (703) 776-3167 Tissue and Genetic Research Protection of data related to sample Will data be identifiable

704 views • 26 slides

An overview of reusable surgical textiles in the North American market

Dan Sanchez Vice President Medcrest Textiles Division Medline Industries, Inc. An overview of reusable surgical textiles in the North American market. Medline History. Textiles is our Heritage Started almost 100 years ago as a textile company

383 views • 20 slides

USAID/ USDA Program for Trade Capacity Building on Sanitary & Phytosanitary Issues under CAFTA-DR

USAID/ USDA Program for Trade Capacity Building on Sanitary & Phytosanitary Issues under CAFTA-DR. Geneva, October 6, 2008 Daniel Orellana Regional Coordinator for SPS & TCB. Establishing Priorities. Integrated SPS regulatory information systems

615 views • 18 slides

The Food Label

The Food Label. A terrific teaching tool Nutrition Labeling and Education Act (1994) Nutrition Facts Panel Standardized serving sizes Specific, legal definitions of various terms (e.g., lowfat, light, fat-free). Information Found on the Food Label. Ingredient List

506 views • 17 slides

Tissue Repository Management

Tissue Repository Management. Ann Johnson IRB Administrator, IRB Member. Objectives . Identify the components necessary for management and oversight of tissue repositories used for research. Understand regulatory requirements for managing tissue repositories used for research.

252 views • 17 slides

AllStar Brand Pharmaceuticals

AllStar Brand Pharmaceuticals. Carissa Fafalios Michael Naioti Scott Pinchak Chris Walsh. Mission Statement .

309 views • 15 slides

Radiological Devices Advisory Committee Meeting

297 views • 11 slides

IRB 101: Informed Consent

IRB 101: Informed Consent. Columbia University Medical Center IRB September 22, 2005. Objectives . HHS, FDA Regulations, NY State Law Regarding Informed Consent Waiver of Some or All of the Elements of Informed Consent Waiver of Documentation of Informed Consent Consent Form Tips.

369 views • 11 slides

Webinar On Good Practices in Preparing for an FDA Inspection

This webinar is intended to help you get familiar with how to prepare for and get ready for an FDA inspection.

189 views • 2 slides