Austin, TX (PRWEB) July 25, 2011
The Food and Drug Administration is an agency that is responsible for protecting and promoting public health through the regulation and supervision of food safety and other health-related products. But how much do people know of what this significant bureau of the government does and needs to improve? Readers will find vital information and insights in about this concerns through author Patrick D. Stone’s Bubble Gum Badge: An FDA His-Story.
This new book is a glimpse of what the USFDA does well and what it needs to improve on according to audit reports from the Health and Human Services (HHS) Office of Inspector General (OIG). Here, Stone shares about the documented regulatory affairs 21 CFR compliance experience and advocate for human subject protection and his twelve years of U. S. Food and Drug Administration experience. The book discusses about specialize gene therapy and IRB 21 CFR compliance; regulatory review experience with oncology therapies for most human body systems (vulnerable patient populations included), cardiovascular disease, HIV (President’s emergency plan for AIDS relief / PEPFAR), vaccine studies including Department of Defense test articles, pain management for multiple indications, and other related subjects. Thus, the book looks into:
- Human Subject Protection / ICF process & document review
- Protocol data-validation Auditing / Quality Management / SOP audits
- Bioequivalence Clinical & Laboratory, GMP, cGMP, GLP non-clinical & clinical, GCP, and ICH
- Computer system validation & 21 CFR part 11 compliance / LIMS / Data Management System compliance
- FDA IRB & audit Training and continuing education presentations on FDA Regulatory Strategy
Informative, insightful, and filled with wisdom, Bubble Gum Badge: An FDA His-Story is an interesting and revealing read beneficial to everyone – it is an understanding about FDA regulations and our US/global health care market place products
For more information on this book, interested parties may log on to http://www.Xlibris.com.
About the Author
Patrick D. Stone, M.S. is an Ex-FDA, International Inspection Cadre for bioresearch monitoring (BIMO) and Drugs. Now president of Trade Stone QA. Mr. Stone has 12 years experience as a BIMO monitor for the FDA. Mr. Stone conducted domestic and international inspections of Clinical Investigators for pre-approval of Biologics/Drugs/Devices, Bioequivalence, IRB and Drug manufacturing.
Bubble Gum Badge * by Patrick D. Stone
An FDA His-Story
Publication Date: July 22, 2011
Trade Paperback; $19.99; 110 pages; 978-1-4628-7258-9
Trade Hardback; $29.99; 110 pages; 978-1-4628-7259-6
eBook; $9.99; 978-1-4628-7260-2
Members of the media who wish to review this book may request a complimentary paperback copy by contacting the publisher at (888) 795-4274 x. 7879. To purchase copies of the book for resale, please fax Xlibris at (610) 915-0294 or call (888) 795-4274 x. 7879.