Validation compliance biannual 1996-1997 /
Validation compliance biannual 1996-1997 /
International Validation Forum, Inc
- vi, 848 pages. ; 26 cm
Includes bibliographical references and index
Overview: behind validation; the regulatory world. Government regulation: FDA regulations; EPA regulations; European Union regulations. Situational review: situational review by industry; situational review in the USA; international situational review. Tools for validation: drug inspections; biologics inspections; medical device inspections. Field findings: FDA adverse findings. Future developments: future developments. Appendices: glossary; validation bibliography.
0824797469
Pharmaceutical industry--Data processing--Quality control
Medical instruments and apparatus--Testing--Data processing
599 / V
Includes bibliographical references and index
Overview: behind validation; the regulatory world. Government regulation: FDA regulations; EPA regulations; European Union regulations. Situational review: situational review by industry; situational review in the USA; international situational review. Tools for validation: drug inspections; biologics inspections; medical device inspections. Field findings: FDA adverse findings. Future developments: future developments. Appendices: glossary; validation bibliography.
0824797469
Pharmaceutical industry--Data processing--Quality control
Medical instruments and apparatus--Testing--Data processing
599 / V