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Article CommentaryCommentary

The Reliability-Quality Relationship for Quality Systems and Quality Risk Management

H. Gregg Claycamp, Faiad Rahaman and Jason M. Urban
PDA Journal of Pharmaceutical Science and Technology November 2012, 66 (6) 512-517; DOI: https://doi.org/10.5731/pdajpst.2012.00888
H. Gregg Claycamp
1Office of New Animal Drug Evaluation, Center for Veterinary Medicine (CVM), U.S. Food and Drug Administration (FDA)
Ph.D.
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  • For correspondence: Gregg.claycamp@fda.hhs.gov
Faiad Rahaman
2Office of Compliance, Center for Drug Evaluation and Research (CDER)
M.S.
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Jason M. Urban
2Office of Compliance, Center for Drug Evaluation and Research (CDER)
Ph.D.
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  • Article
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Article Information

vol. 66 no. 6 512-517
DOI 
https://doi.org/10.5731/pdajpst.2012.00888
PubMed 
23183647

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online November 26, 2012.

Copyright & Usage 
© PDA, Inc. 2012

Author Information

  1. H. Gregg Claycamp, Ph.D.1,*,
  2. Faiad Rahaman, M.S.2 and
  3. Jason M. Urban, Ph.D.2
  1. 1Office of New Animal Drug Evaluation, Center for Veterinary Medicine (CVM), U.S. Food and Drug Administration (FDA)
  2. 2Office of Compliance, Center for Drug Evaluation and Research (CDER)
  1. ↵* Correspondence author: H. Gregg Claycamp, Ph.D., FDA Center for Veterinary Medicine, Office of New Animal Drug Evaluation, 7520 Standish Pl., HVF-100, Rockville, MD 20855. E-mail: Gregg.claycamp{at}fda.hhs.gov. Phone: 240-276-8871
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PDA Journal of Pharmaceutical Science and Technology: 66 (6)
PDA Journal of Pharmaceutical Science and Technology
Vol. 66, Issue 6
November/December 2012
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The Reliability-Quality Relationship for Quality Systems and Quality Risk Management
H. Gregg Claycamp, Faiad Rahaman, Jason M. Urban
PDA Journal of Pharmaceutical Science and Technology Nov 2012, 66 (6) 512-517; DOI: 10.5731/pdajpst.2012.00888

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The Reliability-Quality Relationship for Quality Systems and Quality Risk Management
H. Gregg Claycamp, Faiad Rahaman, Jason M. Urban
PDA Journal of Pharmaceutical Science and Technology Nov 2012, 66 (6) 512-517; DOI: 10.5731/pdajpst.2012.00888
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  • Article
    • Abstract
    • Introduction
    • Reliability and Quality
    • Basic Reliability Concepts
    • Contrasting Engineering and Statistical Reliability
    • The Marriage of Quality and Reliability
    • Reliability and Risk
    • Conflict of Interest Declaration
    • Acknowledgments
    • References
  • Figures & Data
  • References
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Keywords

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  • Quality Systems
  • Risk assessment

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