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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

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 It is still one of my favorite standards although it has been already withdrawn by the U.S. government in 1996 because of a policy decision to support industry consensus standards over government directives.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

Food, Drug, and Cosmetic Division Focus on Member Value

by FD&C

Northeast Pharmaceutical GMP/Quality Conference (FDC co-sponsor with Princeton) January 20, 2011..

  • Filetype: pdf
  • Publish date: 2011-01
  • Keywords:Membership

Spotting Inadequate Investigations, Corrective Actions, and Overall Weak Quality/GMP Systems

by Robert D. Seltzer

Northeast Pharmaceutical GMP/Quality Conference (FDC co-sponsor with Princeton)January 20, 2011..

  • Filetype: pdf
  • Publish date: 2011-01
  • Keywords:GMP, Corrective Action,

Microbiology and Auditing

by Don Singer

Northeast Pharmaceutical GMP/Quality Conference (FDC co-sponsor with Princeton)January 20, 2011..

  • Filetype: pdf
  • Publish date: 2011-01
  • Keywords:Microbiology, Auditing

How Pharma Should Monitor itself for GMP Compliance

by Diana Amador-Toro, Director, New Jersey District Office of Rgulatory Affairs, FDA

Northeast Pharmaceutical GMP/Quality Conference (FDC co-sponsor with Princeton)January 20, 2011..

  • Filetype: pdf
  • Publish date: 2011-01
  • Keywords:GMP, Inspection

Certification to Excipient GMP

by Irwin Silverstein

Northeast Pharmaceutical GMP/Quality Conference (FDC co-sponsor with Princeton)January 20, 2011..

  • Filetype: pdf
  • Publish date: 2011-01
  • Keywords:GMP

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