Selected FDA GCP/Clinical Trial Guidance Documents Grouped by Topic:
* FDA Overview and Orientation
* Introduction to GCP
* Part I: General
* Part II: Institutional Review Boards (IRBs) and Informed Consent
* Part III: Drugs and Biologics
* Part IV: Medical Devices
* Part V: Manufacturing Requirements for Investigational Products
* Part VI: Electronic Data
* Part VII: Combined Glossary and Index for all Quality Guidance Documents
Following in the footsteps of Gordon Allport, all of Mindy J. Allport-Settle's books are built on a foundation of psychology and sociology with a focus on improving some aspect of industry through research and education.
Her career in healthcare began when she was a teenager working as an emergency medical technician. Since then, she has joined the U.S. Navy's advanced hospital corps, worked in organ and human tissue procurement, specialized in ophthalmology, and moved on to serve as a key executive, board member, and consultant for some of the best companies in the pharmaceutical, medical device, and biotechnology industry. She has provided guidance in regulatory compliance, corporate structuring, restructuring and turnarounds, new drug submissions, research and development and product commercialization strategies, and new business development. Her experience and dedication have resulted in international recognition as the developer of the only FDA-recognized and benchmarked quality systems training and development business methodology.
Her education includes a Bachelor's degree from the University of North Carolina, an MBA in Global Management from the University of Phoenix, and completion of the corporate governance course series in audit committees, compensation committees, and board effectiveness at Harvard Business School.