Title
|
Author
|
Date
|
| How to Respond to (and Avoid) FDA 483s |
Veriteq, a Vaisala company |
01/24/2011 |
| |
| Drug Safety: Improvement Needed in FDA’s Postmarket Decision-making and Oversight Process |
U.S. Government Accountability Office |
04/24/2006 |
| |
| Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP |
U.S. Food and Drug Administration |
01/19/2006 |
| |
| FDA Guidance: Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment |
U.S. Food and Drug Administration |
03/26/2005 |
| |
| Influenza Vaccine: Current Status, Lessons Learned and Preparing for the Future |
U.S. Food and Drug Administration |
02/18/2005 |
| |
| Guidance for Industry: Computerized Systems in Clinical Investigations |
U.S. FDA (CDER, CBER, CDRH) |
05/10/2007 |
| |
| A Profile of the Pharmaceutical Manufacturing Industry |
U.S. Environmental Protection Agency |
01/20/2006 |
| |
| [Report on] the Food and Drug Administration’s National Drug Code Directory |
U.S. Dept. of Health & Human Services' Office of Inspector General |
08/15/2006 |
| |
| Kick–Starting PAT to Achieve Quality by Design in cGMP Bioprocessing |
TechniKrom, Inc. |
10/02/2006 |
| |
| Software-Based Validation of Processing Systems Following 21 CFR 11 |
Siemens |
04/29/2005 |
| |
| A Perspective on Standards: A Tool for Global Competitive Survival in an Increasingly Complex Regulatory World |
Rockwell Automation |
02/22/2008 |
| |
| Applications Note on Multipurpose Peeler Centrifuges |
Riera Nadeu U.S.A. |
04/29/2005 |
| |
| Unlocking the Power of Pharmacovigilance |
PriceWaterhouse Coopers |
05/28/2007 |
| |
| Process Modeling and Control Challenges in the Pharmaceutical Industry |
Phil Dell'Orco, GlaxoSmithKline |
02/24/2006 |
| |
| U.S.A. GMPs: What Offshore API Manufacturers Need to Know |
Nicholas Buhay, Deputy Director of Manufacturing and Product Quality, FDA's CDER |
02/20/2006 |
| |
| 21 CFR 11: Risks of Noncompliance |
Master Control |
08/24/2005 |
| |
| Handling MSDSs and Global Hazard Communications |
Marshall Denhoff, American Industrial Hygienists Assn. |
04/29/2005 |
| |
| Complimentary Reports: Pharmaceutical Domain Management and Protecting Pharmaceutical Brands |
MarkMonitor |
10/08/2008 |
| |
| Accounting for Risk in Your Asset Management Strategy |
Life Cycle Engineering |
09/23/2009 |
| |
| Compliance, Risk and Cost of Ownership Comparisons for Pharmaceutical Continuous Monitoring: Wired, Wireless and Standalone Monitoring Systems |
Ken Appel, Manager Regulated Markets, Veriteq, a Vaisala company |
02/03/2011 |
| |
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