21 CFR.ppt
New York Washington Seattle Charles J. Raubicheck, Partner ([email protected]) and [email protected] Brian J. Malkin, Partner ([email protected])
Walter Nowocin, PEM Medtronic, Inc., Minneapolis, Minnesota NCSL International Workshop and Symposium, Nashville, TN 16 July, 2013.
SC PDG Cleaning Verification 19 SEP 2013.pdf
Guidance for Industry Process Validation: General Principles and Practices Dr. Mark Tucker, F. Hoffman-La Roche, Ltd.
FDA cGMP Training Program cGMP in the USA Nicholas Buhay Deputy Director Division of Manufacturing & Product Quality Office of Compliance, CDER, FDA.
FDA cGMP Training Program