Alan Schwartz, mdi Consultants, Inc., Great Neck, NY, has of 40 years of FDA regulatory experience. He has been providing strategic planning on FDA regulatory compliance issues since 1978. Prior to mdi, Alan was a Supervisor of field operations for the US FDA. Mr. Schwartz has been an invited speaker on the FDA policy and issues both in the US and internationally. He provides his expertise on the FDA to the medical device industry worldwide with clients in Japan, Korea, China, Taiwan, Germany, Italy, Argentina, Brazil and Canada. He also has a widely read Insight Report and FDA Updates on dealing with the FDA, which could be found on the mdi web site www.mdiconsultants.com. His experience in dealing with FDA inspections, prior to, during and after the FDA Investigator has left, is extensive having personally participated in over 400 FDA inspections. His insight and understanding of the FDA strategy, preparing replies to the FDA 483 and Warning Letters and acting as a third party certification under FDA approval has provided companies with some very novel approaches to dealing with their regulatory problems. mdi Consultants, Inc. was the official consulting company to the Chinese Council for the Promotion of International Trade and the Chinese Council for International Standards to assist Chinese companies to deal with the FDA. mdi has representatives in Korea, Israel and Czech. Mr. Schwartz is on the the Institute of Validation Technology Editorial Advisory Board.