How to develop and manage qualification protocols for FDA compliance

Title:

Author:

Cloud, Phillip A.

ISBN:

9781482207934

Publication Information:

Boca Raton, Fla. : CRC Press, 1999.

Physical Description:

x, 375 p. : ill. ; [ca. 23-29] cm.

Contents:

1. Introduction -- 2. Documentation master lists -- 3. Protocol format and style guide -- 4. Protocol writing through approval -- 5. Qualification testing through certification -- 6. Change control -- 7. Requalification -- 8. Document control -- 9. Electronic documentation database.

Corporate Subject:

United States. Food and Drug Administration.

Subject Term:

Drugs -- Standards.

Medical instruments and apparatus -- Standards.

Pharmaceutical industry -- Standards.

Geographic Term:

United States.

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