Regulatory Expert of the Year You began your career as an FDA investigator in the early ‘70s— how has that foundation shaped your approach as an expert witness today? Working for the U.S. Government at the FDA teaches you how to navigate various situations. One key skill you develop is the ability to listen before responding. You also learn to measure your words carefully to avoid putting yourself in a compromising position. I once had the opportunity to go out on an FDA assignment with the press (CBS TV) to collect samples of freshly caught fish suspected of containing PCBs. When we couldn’t find any freshly caught fish, the reporter had to interview me instead about the issue of contaminated fish. My response had to be appropriate— not based on personal opinion, but on facts. I had to learn to stick strictly to what was known. That was valuable training: listen carefully to the question before answering, and always stick to the facts. With hundreds of quality systems implemented and thousands trained in FDA regulations, what do you see as the most common compliance missteps companies still make? Probably the biggest problem companies face is that—even though management is committed to making good products— they sometimes overlook what’s needed to ensure compliance with manufacturing regulations. Alan Schwartz President and Founder mdi Consultants, Inc. www.mdiconsultants.com Alan Schwartz, President and Founder of mdi Consultants, Inc., has decades of experience in FDA regulatory affairs, quality assurance, and international compliance. He brings a rare blend of hands-on expertise and strategic insight to his role as an expert witness. In this interview, he shares how his foundational years at the FDA shaped his approach, the pitfalls companies still face, and what distinguishes a truly effective regulatory affairs expert in today’s complex landscape. USA
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