Areas of Expertise: Food & Drug
A former US FDA Supervisor of Field Operations, with over 49 consecutive years of FDA regulatory experience covering the medical device, pharmaceutical and food industries. An invited speaker on FDA compliance worldwide and a recognized FDA QSR experts by the FDA for third party audits and compliance certification as well as regulatory mediation.
After a successful stent with the FDA, he founded mdi Consultants, Inc., and has worked with companies worldwide on all aspects of the FDA compliance. Services include: setting up quality systems for FDA compliance to the QSR and/or cGMPs, FDA strategic planning, Assisting with recalls and product removals, interacting with the FDA inbehalf of the company, responding to 483 and W/Ls.
Preparation and submission of 510(k)s and PMAs. Management and Employee training programs on all aspects of the FDA compliance.
Articles published by Medical Device Executive Magazine, MDDI Magazine, mdi's website, and various other websites.
Acted as expert witness of various legal cases on FDA and liability issues. Reviewed documents, gave written opinion, provide strategy planning. Given depositions and testified in behalf of clients.