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Displaying fda PowerPoint Presentations

Proposed Rules to Help Ensure the Safety of Imported Food PPT

Presentation Summary : Proposed Rule for Preventive Controls for Animal Food http://www.fda.gov/fsma * * * A reasonably foreseeable hazard is a potential biological, chemical, physical or ...

Source : http://www.fda.gov/downloads/Food/GuidanceRegulation/FSMA/UCM373019.ppt

FileNewTemplate - Food and Drug Administration PPT

Presentation Summary : Proposed Rules under the FDA Food Safety Modernization Act Version 1/8/2013 Five Proposed Rules Establish Food Safety Framework Produce Safety Standards - Published ...

Source : http://www.fda.gov/downloads/Food/GuidanceRegulation/UCM334722.ppt

Chemistry, Manufacturing, and Controls (CMC) and Good ... PPT

Presentation Summary : CMC helps maintain the connection in quality between the drug used in clinical studies and the marketed drug. Drug marketed to consumers. Commercial product

Source : http://www.accessdata.fda.gov/static/cvm/cormier/CMCsandGMPs.pptx

FDA: History and Organization - Louisiana State University PPT

Presentation Summary : Title: FDA: History and Organization Author: Edward Richards Last modified by: Edward Richards Created Date: 9/27/2002 1:54:04 PM Document presentation format

Source : http://biotech.law.lsu.edu/cphl/slides/FDA_history.ppt

Toxicology Human Food Safety Assessement PPT

Presentation Summary : 6/14/2012. FDA/CVM. Overview of human food safety evaluation. Toxicology assessment principles. Toxicological assessment of animal drugs for food animals

Source : http://www.accessdata.fda.gov/static/cvm/zhou/ToxicologyAssessmentUpdated.pptx

FDA Regulation of Pharmaceuticals and Devices PPT

Presentation Summary : FDA Regulation of Pharmaceuticals and Devices Jean Toth-Allen, Ph.D. Good Clinical Practice Program Office of Science and Health Coordination Office of the Commissioner

Source : http://www.ihs.gov/Research/docs/NativeAmericanconference.ppt

FDA Inspections, Compliance Review and Quality Systems Regulation PPT

Presentation Summary : U.S. FDA Approach to Auditing Including QSIT Christine Nelson Center for Devices & Radiological Health Food & Drug Administration FDA-Speak Terms Inspection = Audit ...

Source : http://www.fide-online.org/downloads/Chris_Nelson_-_FDA_Approach_to_Auditing.ppt

FDA - MassBio PPT

Presentation Summary : FDA Inspection Preparation and Management Massachusetts Biotechnology Council April 28, 2009 David L. Chesney, Vice President Strategic Compliance Services

Source : http://www.massbio.org/writable/committees/presentations/fda_inspection_preparation_and_management.ppt

FDA - NY/ NJ Foreign Freight Forwarders + Brokers ... PPT

Presentation Summary : FDA Import Process Import Process IMPORT PROCESS Importer or agent files entry documents with Customs FDA Reviews documents which include CBP 3461, invoice, bill of ...

Source : http://www.nynjforwarders-brokers.org/clientuploads/Forms/Import_Procress.pps

The FDA - Texas A+M University PPT

Presentation Summary : Title: The FDA Author: Ljlab Last modified by: Ljlab Created Date: 10/10/2007 9:44:15 PM Document presentation format: On-screen Show (4:3) Company

Source : http://peer.tamu.edu/VBB/Lessons/DH/FDA%20Role%20in%20Medicine%20Safety%20and%20Use/FDA%20Role%20in%20Medicine%20Safety%20and%20Use.ppt


Presentation Summary : fda clinical trial requirements for medical devices neil f. o’flaherty principal olsson frank weeda terman bode matz pc medical device clinical research and ...

Source : http://www.ofwlaw.com/CM/Custom/FDA%20CLINICAL%20TRIAL%20REQUIREMENTS%20FOR%20MEDICAL%20DEVICES.PPT

Clinical Trial Quality and Compliance: An FDA Perspective PPT

Presentation Summary : Title: Clinical Trial Quality and Compliance: An FDA Perspective Author: CDER USER Last modified by: mbuxton Created Date: 3/21/2000 1:32:16 PM Document presentation ...

Source : http://phirst.jhsph.edu/sph/Doc/0/64NOQ781QI2KR0VG22SFR98V2E/FDA_slides.ppt

FDA - Introduction to Drug Regulation - Medical and Public ... PPT

Presentation Summary : FDA - INTRODUCTION TO DRUG REGULATION Edward P. Richards Director, Program in Law, Science, and Public Health Louisiana State University Law Center

Source : http://biotech.law.lsu.edu/cases/FDA/FDA_introduction.ppt

Analysis Datasets in FDA Submissions 1. A History Lesson PPT

Presentation Summary : Title: Analysis Datasets in FDA Submissions 1. A History Lesson Last modified by: Dave Christiansen Created Date: 5/20/2004 9:43:28 PM Document presentation format

Source : http://www.amstat.org/meetings/fdaworkshop/presentations/2005/P07_Christiansen_CDISC.ppt

FDA CDRH Organizational Structure + Overview PPT

Presentation Summary : Title: FDA CDRH Organizational Structure & Overview Author: Carole C. Carey Last modified by: IEP Events Created Date: 2/24/2008 12:36:01 PM Document presentation format

Source : http://www.axendia.com/Advamed08/Carey.ppt

An FDA Audit: What the Investigator Needs to Know PPT

Presentation Summary : An FDA Audit: What the Investigator and Sponsor Need to Know Joseph P. Salewski, Chief Bioresearch Monitoring Branch Center for Biologics Evaluation and Research

Source : http://www.asgct.org/archived_course_materials/training_course/salewski.ppt

FDA's Bioresearch Monitoring Inspections - NIH VideoCasting ... PPT

Presentation Summary : FDA Inspections Patricia Holobaugh Chief, Bioresearch Monitoring Branch Division of Inspections and Surveillance Office of Compliance and Biologics Quality

Source : http://videocast.nih.gov/ppt/NIAID_gcp_041505.ppt

Overview of FDA Device Regulations - University of Arizona PPT

Presentation Summary : Overview of FDA Device Regulations Bob Assenzo Critical Path Institute bassenzo@c-path.org Overview of FDA Device Regulations - Outline Introduction Establishment ...

Source : http://www.bme.arizona.edu/courses/696cfiles/CPATH_DevicesOverviewOfRegulationsFeb252008.pps

A Comprehensive Introduction to the Out-Of-Specification FDA ... PPT

Presentation Summary : Title: A Comprehensive Introduction to the Out-Of-Specification FDA Guidance Author: Torbeck & Assoc. Last modified by: Torbeck & Assoc. Created Date

Source : http://pharmstat.com/files/oos-guidance.ppt

FDA Common Findings - Office of Research + Development PPT

Presentation Summary : FDA’s BIMO Inspection Program and IRB Inspections. VA IRB Chairs Meeting. August 2012. Janet Donnelly RAC, CIP. Office of Good Clinical Practice . Office of the ...

Source : http://www.research.va.gov/programs/PRIDE/conferences/docs/irb2012/Donnelly.pptx

FDA’s Role in Protecting and Promoting Public Health PPT

Presentation Summary : Title: FDA’s Role in Protecting and Promoting Public Health Author: mary.hitch Last modified by: Michael Koronkowski Created Date: 1/19/2006 9:37:50 PM

Source : http://www.uic.edu/com/dom/gim/FLIP/Documents/FDA_Roles_Limitations_2007.ppt

Recent FDA Guidance on Exploratory IND: Tool for Expediting ... PPT

Presentation Summary : The Exploratory IND Guidance “Phase 0” Trials in Oncologic Drug Development September 5, 2007 David Jacobson-Kram, Ph.D. DABT Office of New Drugs

Source : http://dctd.cancer.gov/MajorInitiatives/Sep0507Phase0Workshop/DrDavidJacobson-Kram090507.pps

Role of FDA in Guiding Drug Development - NIH Clinical Center ... PPT

Presentation Summary : Principles of Clinical Pharmacology NIH, April 26, 2007 Role of FDA in Guiding Drug Development Carl Peck Center for Drug Development Science UCSF, UC-Washington Center

Source : http://www.cc.nih.gov/researchers/training/principles/ppt/Peck_2006-2007.ppt

Health Economics and FDAMA Laurie B. Burke, DDMAC, FDA PPT

Presentation Summary : Off-Label Drug Use: View from the U.S. FDA Laurie B. Burke, RPh, MPH Chief, Managed Care, Outcomes and Labeling Staff, DDMAC, CDER, FDA Tokyo, Japan April 23, 1998 ...

Source : http://homepage3.nifty.com/cont/26sup/FDA-OLU.ppt

Differences in OHRP, FDA and ICH Regulations/Guidelines PPT

Presentation Summary : Differences in OHRP, FDA and ICH Regulations/Guidelines. Monika Haugstetter, MHA, MSN, RN. Human Subject Protection Office (HSPO) and Institutional Review Board (IRB ...

Source : http://hspo.uchc.edu/education_resources/ppt/Differences%20in%20OHRP%20%20FDA%20and%20ICH%20Regulations%20PUBLIC.pptx

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