TY - BOOK ED - International Validation Forum, Inc TI - Validation compliance biannual 1996-1997 SN - 0824797469 U1 - 599 21 PY - 1996/// CY - New York PB - M. Dekker KW - Pharmaceutical industry KW - Data processing KW - Quality control KW - Medical instruments and apparatus KW - Testing N1 - Includes bibliographical references and index N2 - 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 ER -