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Library,Documentation and Information Science Division

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Process validation for business success / [electronic resource] Adrian E. Elfe, Jayme P. Lahey, Robert G. Launsby.

By: Contributor(s): Material type: TextTextPublication details: [Colorado Springs, Colo.] : Launsby Consulting, c1995.Description: 1 v. (various pagings) : ill., forms ; 23 cmISBN:
  • 0963609343
  • 9780963609342
Subject(s): Online resources:
Contents:
Chapter 1. Process validation, the FDA and your business -- Chapter 2. Design control and process validation -- Chapter 3. Planning a product your customer will buy! -- Chapter 4. Other tools for success -- Chapter 5. Design of experiments-A good business tool -- 6. Validation planning -- Appendix A. Guideline on general principles of process validation -- Appendix B. Preproduction quality assurance planning -- Appendix C. Guideline for the manufacture of in vitro diagnostic products.
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Includes index.

Includes bibliographical references (p. C-27 - C-28).

Chapter 1. Process validation, the FDA and your business -- Chapter 2. Design control and process validation -- Chapter 3. Planning a product your customer will buy! -- Chapter 4. Other tools for success -- Chapter 5. Design of experiments-A good business tool -- 6. Validation planning -- Appendix A. Guideline on general principles of process validation -- Appendix B. Preproduction quality assurance planning -- Appendix C. Guideline for the manufacture of in vitro diagnostic products.

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