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FDA Inspections of Clinical Investigators: Are You Ready?

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White Paper 7 FDA Inspections of Clinical Investigations: Are You Ready? (2) "Information Sheet Guidance for IRBs, Clinical Investigators, and Sponsors: FDA Inspections of Clinical Investigators" (3) "Guidance for Industry: Investigator Responsibilities—Protecting the Rights, Safety, and Welfare of Study Subjects" (4) "In the FDA Spotlight: Investigators and Sponsors" by James Hamilton, Life Science Leader (5) Regulation of the European Parliament and of the Council on Medical Devices, and Amending Directive 2011/83/EC, Regulation (EC) No. 178/2002 and Regulation (EC) No. 1223/2009 (6) Commission Directive 2005/28/EC (7) FDA warning letter sent to Michael Ring, M.D. (8) FDA warning letter sent to John Caton Jr. (9) FDA warning letter sent to Martin McKay, SVP, Global R&D, Pfizer (10) FDA warning letter sent to Robert Deitz (11) FDA Warning Letter sent to Linda Bosseman (12) FDA warning letter sent to Damien Sanderlin, MD. (13) Supra notes 7 and 8. (14) Supra note 9. (15) Supra notes 10 and 12. About MasterControl MasterControl Inc. creates software solutions that enable life science and other regulated companies to deliver life-improving products to more people sooner. MasterControl's integrated solutions accelerate ROI and increase efficiencies by automating and securely managing critical business processes throughout the entire product lifecycle. More than 1,000 companies worldwide, ranging in size from five employees to tens of thousands, rely on MasterControl cloud solutions to automate processes for new product development, clinical, regulatory, quality management, supplier management, manufacturing and postmarket surveillance. MasterControl solutions are well-known for being scalable, easy to implement, easy to validate and easy to use. For more information, visit www.mastercontrol.com. © 2019 MasterControl Inc. All rights reserved. WPXXXXUSENLT-02/19

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