This blog seeks to talk about issues of importance to the Food and Drug Administration, regulatory compliance, and GxP best practice. It is meant for those of us who work in the life sciences as GxP professionals, particularly quality assurance professionals but hopefully it has information of interest to the general public.
It is told from the perspective of Carl Anderson, a Tacoma, WA based regulatory affairs and quality assurance consultant in the field of FDA health product approvals including drugs, biologics, and medical devices. There are also a number of contributions by other GxP professionals. Please see the Guest Commentaries page for more information.
About the editor:
From 1987 to 2005 Carl worked for the United States Food and Drug Administration. In 1994 Carl began conducting inspections in the Bioresearch Monitoring program and inspected clinical investigators, institutional review boards, nonclinical laboratories, and sponsors of clinical research. He was on the FDA’s international inspection cadre and has conducted audits and inspections in Canada, Europe, the Middle East, and East Asia.Since leaving FDA Carl has done well and had fun. He is currently not accepting new clients and recommends some of the Guest Contributers who have written for the blog the past few years.
Carl’s email is: email@example.com
GxP Perspectives on twitter: @GxPPerspectives