Editor(s): James K. Shillenn
The first reference source of its kind dedicated to current innovative approaches to high standard validation practices for biotechnological uses in the pharmaceutical industry.
12 comprehensive peer-reviewed papers cover the following critical areas: Facilities and Equipment Validation; Process Validation and Planning; and Calibration and Change Control.
ST Fay, TP Howard, WT Stevens
JM Martin, S Cole, G Geerligs, G Howard, R Jaenchen
FP Simione, JZ Karpinsky
RW Stotz, AR Bluhm
PR Levison, M Streater, RMH Jones, ND Pathirana
WC Steere, LA Scheer, M Hubbert
KS Sniff, LA Garcia, RA Hassler, RJ Seely, MD Young
BY Zaslavsky, DJ Chaiko