Elfe, Adrian E. Process validation for business success / [electronic resource] / Adrian E. Elfe, Jayme P. Lahey, Robert G. Launsby.. — [Colorado Springs, Colo.] : : Launsby Consulting,, c1995.. — 1 v. (various pagings) : : ill., forms ; 23 cm.

Includes index.

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

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



ISBN: 0963609343 9780963609342

LCCN: 95075982

Subjects--Topical Terms:
Quality assurance--Management.
Process control--Statistical methods.