| 000 | 01454nam a2200313 i 4500 | ||
|---|---|---|---|
| 999 |
_c12548 _d12548 |
||
| 001 | 35444539 | ||
| 005 | 20210223091415.0 | ||
| 008 | 960909s1996 nyu b 001 0 eng d | ||
| 020 | _a0824797469 | ||
| 035 | _a.b45311717 | ||
| 040 |
_aEET _cEET _dEG-NFue _erda |
||
| 049 | _aOSUU | ||
| 082 | 4 |
_221 _a599 _bV |
|
| 090 | _b.V351 1996-1997 | ||
| 090 | _b.V351 1996-1997 | ||
| 245 | 0 | 0 |
_aValidation compliance biannual 1996-1997 / _cInternational Validation Forum, Inc |
| 264 | 1 |
_aNew York : _bM. Dekker, _c1996 |
|
| 300 |
_avi, 848 pages. ; _c26 cm |
||
| 336 |
_2rdacontent _atext |
||
| 337 |
_2rdamedia _aunmediated |
||
| 338 |
_2rdacarrier _avolume |
||
| 504 | _aIncludes bibliographical references and index | ||
| 520 | 0 | _aOverview: 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. | |
| 650 | 0 |
_aPharmaceutical industry _xData processing _xQuality control |
|
| 650 | 0 |
_aMedical instruments and apparatus _xTesting _xData processing |
|
| 710 | 2 | _aInternational Validation Forum, Inc | |
| 942 |
_2ddc _cBK |
||