'Design control' presentation slideshows

ISO

1.07k views • 64 slides

Design Bases From 1957 to 2003 June 18, 2007 Chuck Casto Region II NRC

Design Bases From 1957 to 2003 June 18, 2007 Chuck Casto Region II NRC. HISTORY OF DESIGN BASES. Atomic Energy Act of 1954 (1957 Thru 1962) Section 182 Technical Specifications are part of license Implemented in 10CFR50.34 & 50.36 Hazards Summary Report Safety Analysis Report.

764 views • 41 slides

AEROSPACE QUALITY MANAGEMENT SYSTEM 9100

AEROSPACE QUALITY MANAGEMENT SYSTEM 9100. Dale K. Gordon Past Chairman Americas Aerospace Quality Group SAE Aerospace Committee G-14 March 14th 2002. Aerospace Quality Standards Numbering System. International Standards - 91xx

790 views • 37 slides

Failure Mode and Effect Analysis

Failure Mode and Effect Analysis. Jackie Harris, Josh Agusti , and Natasha Sommer. Objectives. What is FMEA? Why is an FMEA important? History of FMEA Benefits of FMEA Limitations of FMEA How to conduct an FMEA?. Who is in Attendance?. Anyone conducted an FMEA before?

663 views • 34 slides

How to Enhance the Value of Your Construction Firm Presented by: Randy Stutzman

417 views • 33 slides

Training Program Overview Produced by LeBlond & Associates, LLC

379 views • 25 slides

604 views • 24 slides

Panel Discussion Safety Culture

Panel Discussion Safety Culture. Richard Lagdon, Chief of Nuclear Safety, Office of the Under Secretary for Nuclear Security. Panel Members. Matthew Moury, Deputy Assistant Secretary for Safety, Security and Quality Programs Office of Environmental Management Don Nichols,

406 views • 23 slides

Chapter 7

Chapter 7. Causal Designs. Issues Addressed. conditions of causality what is an experiment? differences between a lab vs field experiment two types of experimental validity extraneous factors that affect validity types of experimental designs test marketing and types of test markets.

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When do I need an IND ?

386 views • 19 slides

Agenda and Background

258 views • 15 slides

A Biotechnology-based Manufacturing Business-Training Enterprise

226 views • 15 slides

A Biotechnology-based Manufacturing Business-Training Enterprise

227 views • 15 slides

Computer Architecture and Design ELEC 5200/6200 Class Project Overview

279 views • 14 slides

Biomedical Engineering Design and the Promotion of High Value Relationships with Clinical Medicine

Biomedical Engineering Design and the Promotion of High Value Relationships with Clinical Medicine. Robert Hitchcock. Background. A highly regulated industry. Collaborative development environment. Utah BioDesign. University resources and vision. Course Highlights.

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221 views • 10 slides

Part 15 Public Hearing FDA Regulation of Combination Products November 25, 2002 Rockville, MD

Part 15 Public Hearing FDA Regulation of Combination Products November 25, 2002 Rockville, MD. Michael Gross, Ph.D., RAC Vice-President Worldwide Compliance Aventis Behring King of Prussia, PA michael.gross@aventis.com. PERSONAL EXPERIENCE. Inhalation device [510(k)]

306 views • 9 slides

Using the Design-Build Approach to Meet Energy Reduction Goals

Using the Design-Build Approach to Meet Energy Reduction Goals. March 2012. University of California, Irvine. 457 Buildings comprising 5,480,000 ASF 1,478 acres main campus $16M annual utilities budget Lab buildings consume 2/3 of campus energy. Statewide Energy Partnership.

160 views • 8 slides

Product Lifecycle of an IDE

Product Lifecycle of an IDE. Design Controls 21 CFR 820.30. Design and Development Planning Design Input Design Output Design Review. Design Verification Design Validation Design Changes Design History File. Design Control Subsystem. Design Controls Purpose.

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Why Is It Important To Have Design Control Medical DeviceFor Your Organization?

The main objective of the design control medical device system is to follow, report and establish a methodological proven process to develop a product especially related to the medical device.

31 views • 2 slides