I have 40 years of experience, and specialize in the field of medical devices and drugs with specific knowledge in the areas of good manufacturing practice regulations, quality system management and process validation and complaint handling. I have published on such topics as auditing, training and quality terminology. I once worked for a company that went under consent decree. An independent consulting firm subsequently reviewed my departments audit reports and found that we had identified every 483, warning letter and consent decree item at least once. Management was advised of all the problems, they just didn’t fix them. I was retained and told to keep doing what I was doing.I once audited a plastic injection molder and rejected them. I indicated that the plant could easily catch on fire. It burned to the ground 3 days later.