Library

Federal, State, and Local Regulatory Integration

by Brett Weed, State Liaison (NC/SC), FDA Atlanta Dist.

  • Filetype: pdf
  • Publish date: 2013-09
  • Keywords:FDA

The Reproducibility Crises in Biomedical Research and its Impact on Pharmaceutical R&D Productivity

by Ülo Palm

  • Filetype: pdf
  • Publish date: 2013-02
  • Keywords:biomedical research, collective intelligence, pharmaceutical drug development, productivity, quality, reproducibility

Complaint Handling

by Marie Mathews

  • Filetype: pdf
  • Publish date: 2013-02
  • Keywords:Pharmaceutical

Pitfalls to Cleaning Validation

by Compton, Cathelene;

Presentation at the SE Conference..

  • Filetype: pdf
  • Publish date: 2013-02
  • Keywords:FDA

Statistics in the Pharmaceutical Manufacturing World

by Vining, Geoff;

Presentation from ASQ SE Conference 2012..

  • Filetype: pdf
  • Publish date: 2013-02
  • Keywords:FDC

Field Alert Reporting System

by Matta, Viviana;

Presentation for field alerts by the FDA at SE Conference 2012..

  • Filetype: pdf
  • Publish date: 2013-02
  • Keywords:FDA

MIL-Q-9858A, the Origin of ISO 9001

by Akio Miura, CQA/CQE/CQ Manager/CRE/Certified Six Sigma BB, Chairman, International Quality Assurance Institute, Tokyo, Japan

Military Specification MIL-Q-9858A (Quality Program Requirements) of the U.S.government (first issued as MIL-Q-9858 on April 9, 1959 and revised to MIL-Q-9858A on December16, 1963) is the origin of ISO 9001 standard and all other quality management system standards and regulations over the world. I would like to present its outline in this article. MIL-Q-9858A is titled “specification”, because it was intended to be used as a contract specification for military contractors. However, it is actually a “quality management system standard” in its nature. It is still one of my favorite standards although it has been already withdrawn by the U.S. government in 1996 because of a policy decision to support industry consensus standards over government directives.

  • Filetype: pdf
  • Publish date: 2012-06
  • Keywords:US Army

The Fundamentals of Developing and Implementing a HACCP-based Risk Management System: Hazard Analysis and Critic-20111108 0043-1

Webinar by the Food, Drug and Cosmetic Division...

  • Filetype: wmv
  • Publish date: 2011-11
  • Keywords:

How We Lead Change

June 27, 2011 Joint meeting between the FD&C Division and the San Fernando Valley Section..

  • Filetype: pdf
  • Publish date: 2011-08
  • Keywords:

Free Webinar to Make Sense of New FDA Regulations

by Qualtrax Compliance Software

  • Filetype: pdf
  • Publish date: 2011-03
  • Keywords:

ASQ News

 

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