Discussion Regarding FDA Guidance for Industry on Process Validation: General Principles and Practices, January 2011, Current Good Manufacturing Practices (CGMP) Revision
Martin Browning is the President and Co-Founder of EduQuest, Inc., a global team of FDA compliance experts based near Washington, D.C. Martin has more than 30 years of regulatory experience at the FDA and as a highly sought-after advisor to industry. His 22-year career at FDA included work in the field offices as an investigator and as a senior manager in the Office of Regulatory Affairs at FDA headquarters. He capped his FDA career by serving as a special assistant to the Associate Commissioner for Regulatory Affairs. He also served as vice chair of FDA’s electronic record and signature working group, where he helped draft the original 21 CFR Part 11 regulations. In addition, Martin served as the chair of the U.S. government’s ISO 9000 committee and was a member of the FDA committee that developed the medical device Quality System Regulation (QSR). At EduQuest, Martin helps clients solve problems related to FDA regulation, quality assurance, software and systems engineering, and compliance auditing, including the assessment of vendors and outsourced operations. His specific experience also includes quality systems design, system design assurance and verification, and the validation of biopharmaceutical and device systems, processes and software. Martin is the chairman and developer of many of EduQuest’s popular training courses, including the three-day FDA Auditing of Computerized Systems and Part 11 course. This class is based on the program EduQuest originally developed at FDA’s request to train agency field investigators, analysts and compliance staff on Part 11 rules and the inspection of computerized systems. He has been the featured keynote speaker for industry conferences held throughout the U.S. and overseas, and he has published many articles in the trade press. In addition, Martin has written EduQuest Advisory papers on “The Hot Potato of Responsibility: How to Manage Outsourcing and Not Get Burned” and “Medical Device Concessions: Free Pass or Red Flag for Your Quality System?”. He was named Speaker of the Year in 2004 by the Institute of Validation Technology (IVT) and has received dozens of other awards from the FDA, DIA, ASQ, and other industry organizations.