This expert has 39 years of experience, and specializes in the field of federal drug administration (FDA) regulatory affairs and quality assurance compliance with specific knowledge in the areas of medical devices, pharmaceuticals and foods. He has published on such topics as FDA compliance issues, dealing with the FDA and importing products to the USA. He has testified 7 times on topics such as quality systems registrarsâ€šÃ„Ã´ compliance issues, FDA submissions and regulatory problems and concerns. He has worked with companies worldwide and has visited over 1000 companies in the 38 years in this area. This expert has been an invited guest lecturer and worked with the governments of China, Taiwan, Thailand and Brazil.