New Jersey Quality System Auditing Expert #15371

I have 38 years of experience, and specialize in the field of FDA technical support with specific knowledge in the areas of quality system auditing, CMC section writing for FDA submissions and analytical chemistry. I have published on such topics as analytical chemistry in a GMP environment, spectroscopy and statistics. I have testified on product liability, FDA non-compliance and patent infringement. Participated for 7 years in Johnson & Johnson corporate training program for laboratory workers. Wrote chapters on statistics and spectroscopy in textbook.

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