David S. O’Connor is a Senior Director at Lachman Consultants and an accomplished Quality Assurance professional with over thirty years of experience in pharmaceutical research from a sponsor, Contract Research Organization (CRO), and consulting perspectives. He has extensive QA experience in all aspects of Clinical (GCP) and Preclinical (GLP) studies and experience with Manufacturing (GMP) […]
Scott Deckebach, M.B.A., is a Senior Director in the Compliance Practice at Lachman Consultants with more than 25 years of experience in the life sciences including APIs, pharmaceuticals (RX and OTC) biopharmaceuticals, aseptics, and medical devices. Mr. Deckebach has extensive quality systems design and remediation experience. He develops IT strategies and solutions and is a […]
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 […]
Marian Meyer, Ph.D., is a Senior Director at Lachman Consultants who assists clients in FDA compliance of microbiology and chemistry laboratories, quality control, quality assurance, and operational activities. Dr. Meyer had served as a member of the USP Monograph Development: Psychiatrics and Psychoactives Expert Committee and on the USP Small Molecules 4 Expert Committee. She has […]
Tamil Arasu, Ph.D. is a Principal Consultant at Lachman Consultants who brings a unique background of both U.S. FDA and pharmaceutical industry experience to Lachman clients. He is an expert in cGMP and ICH guidelines and had conducted FDA pharmaceutical inspections as lead investigator in more than 10 countries prior to joining Lachman Consultants. His […]
Patrick Day, M.S. is a Principal Consultant in the Compliance Practice at Lachman Consultants and an established pharmaceutical executive and practitioner with proven leadership in proactive risk identification, deployment of strategies to enhance compliance controls, and implementation of detection systems to eliminate blind spots. He is skilled in policy deployment as well as in leading […]
Jennifer Leaming, RAC is a Principal Consultant at Lachman Consultants and a dedicated regulatory professional with 20 years of experience in the pharmaceutical industry. She delivers expertise in guidance and regulation to Lachman clients in order to balance production and compliance of drug and drug-device combination products throughout their lifecycle. She crafts strategies and provides […]
Joseph S. Posada, is a Consultant at Lachman Consultants in the Science and Technology practice who has more than 30 years of pharmaceutical experience offering GMP compliance, scientific expertise and leadership excellence in Analytical Research & Development and QC Laboratory environments. Mr. Posada is a highly effective communicator with strong attention to detail. His core […]
Rebecca (Becky) Welton is a Consultant at Lachman Consultants who is an experienced Science, Operations, and Regulatory leader with 25+ years in the pharmaceutical industry holding positions of escalating accountabilities in chemistry, formulation, management, pilot plant manufacturing, and regulatory affairs. She is well-versed in areas of solid dosage generic product development, R&D pilot plant start-up […]
