Team Members

Rhonda L. Ezell, M.S., Director in the Compliance Practice at Lachman Consultants with 30 years experience in the food and drug industry that includes extensive experience in microbiology, quality, and compliance. She is well versed in US FDA and foreign regulatory authority regulations. She is the author of the chapter, “Determination of Objectionable Organisms in Non-Sterile Pharmaceutical Products—A Science-Based Risk Assessment Approach” in the book, Microbial Identification: The Keys to a Successful Program by Mary Griffin and Dona Reber, Editors, published by the Parenteral Drug Association (PDA). She has extensive teaching and training experience in manufacturing and industrial operations as well as corporate training; designed training programs for microbiology, sanitation, GMPs, FDA regulations, regulatory inspections, subject matter expert presentations, and train-the-trainer programs. She has spoken at the Institute of Validation Technology (IVT) Aseptic Processing Conference and their Contamination Control Week on objectionable microorganisms and microbial control as well as at other conferences and forums, including PDA. Her experience includes active pharmaceutical ingredients, finished dosage forms (liquids, solid orals, capsules, ointments, injectables).