White Papers

Title Author Date Development of FDA-Regulated Medical Products Elaine Whitmore, ASQ Quality Press 05/02/2007   Guidance for Industry: Computerized Systems in Clinical Investigations U.S. FDA (CDER, CBER, CDRH) 05/10/2007   Unlocking the Power of Pharmacovigilance PriceWaterhouse Coopers 05/28/2007   Draft Guidance : Bioequivalence Recommendations for Specific Products Food & Drug Administration 06/04/2007   How to Prepare for an Inspection of Your Company's Information Integrity Cerulean Associates LLC 07/25/2007   Official File : Novartis Complaint 07/27/2007   Amendment to the cGMP Regulations for Finished Pharmaceuticals FDA 12/07/2007   A Perspective on Standards: A Tool for Global Competitive Survival in an Increasingly Complex Regulatory World Rockwell Automation 02/22/2008   Achieving Manufacturing Process Excellence with Quality by Design, Design Space Development, Design for Manufacturing and PAT Aegis Analytical 08/11/2008   How New Technologies Can Improve Compliance in Pharmaceutical and Biotech Manufacturing Justin Neway, Aegis Analytical 08/12/2008   Complimentary Reports: Pharmaceutical Domain Management and Protecting Pharmaceutical Brands MarkMonitor 10/08/2008   “Thin LIMS” IT Implementation Strategy for cGMP Quality Informatics 11/14/2008   Imperfect Harmony: Life Sciences Companies Must Partner to Thrive IBM 03/16/2009   Current Trends in GMP Warning Letters Hogan & Hartson LLP 05/22/2009   Integrating Good Manufacturing Practices During the Transition from Clinical Trials to Commerical Manufacturing CDC Software 06/11/2009   Accounting for Risk in Your Asset Management Strategy Life Cycle Engineering 09/23/2009   Enhancing Collaboration with the FDA Through MedWatch Plus ETQ Inc. 02/08/2010   FDA Transparency Initiative: Opening FDA's 'Black Box' Afia K. Asamoah, published by FDLI 02/23/2010   Joining Forces: Bringing Pharma Supply Chain Management and Supply Quality Management Together 08/03/2010   How to Respond to (and Avoid) FDA 483s Veriteq, a Vaisala company 01/24/2011   Search Result: 21 - 40 of 45 Prev 20  |  Next 5