Articles from Validation Times (June 1, 2000)

Title	Author	Type	Words
Analysis of 483s/EIRs for GMP validation issues.	McCarty, Mark	Brief Article	1006
Analytical methods - Firms want less supplements, but FDA's Sheinin sounds bell.		Brief Article	847
CBER guidance said to be held up by CDER worries.	Reid, Ken	Brief Article	293
Checklist, software for devices seen helpful in gauging E-sig compliance.	Lawrence, Terry	Brief Article	884
Comparability protocols - USP group wants ICH to write comparability protocol guide.		Brief Article	520
Devices/Biologics.			1352
Environment, security focus of Part 11 audits.	Lawrence, Terry	Brief Article	787
Generic, innovator firms seek harmonized GMPs.	Fields, Howard	Brief Article	719
Guidance/Regulation Tracker.		Brief Article	386
Need 10-15 years to comply with Part 11: OTC lobbyist.	Dechnik, Peter	Brief Article	541
Warning Letter Analysis.		Brief Article	2531