FDA Compliance Expert in Pharmaceutical Manufacturing

Case Description:

An FDA compliance expert was sought for a wrongful termination case brought against a pharmaceutical manufacturer. The expert was needed to consult on quality control testing procedures for the pharmaceutical manufacturing process. The plaintiff was employed as a quality control chemist who repeatedly notified his employer that a discrepancy report for discovered errors was required for FDA compliance. Management agreed but the documentation never occurred. Plaintiff contended that his termination was a result of his persistent attempts to ensure FDA compliance with regulatory policies and the company's attempts to hide the situation.

IMS ExpertServices was asked to find an FDA compliance expert in pharmaceutical regulatory policies. The expert would preferably be a former FDA employee experienced in the regulations that govern the pharmaceutical industry. The client sought an expert who could speak to the importance of FDA regulatory compliance and the consequences of failing to maintain FDA compliance.

Experts Presented:

  • Regulatory Compliance

    This regulatory compliance expert has almost 20 years of regulatory experience in the administration and management of pharmaceutical development. She has worked in regulatory compliance with the FDA and pharmaceutical companies and has been hands-on with the product development process. She earned her B.S. in biology and her M.S. in technology management, specializing in biotechnology. As a regulatory officer with the FDA, this expert was responsible for enforcing regulatory compliance in pharmaceutical manufacturing. IMS Reference #5007266

  • FDA Regulatory Policies

    This FDA compliance expert in FDA regulations is a consultant providing regulatory, compliance and quality assurance guidance to the biologics, tissue banking and pharmaceutical industries. He was a compliance officer, inspector and compliance director during his more than 20 years at the FDA. He routinely evaluated FDA compliance with pharmaceutical industry regulations, including GMPs and quality control activities. He earned his B.S. in pharmacy as well as his Master of Public Health degree. In his years as an inspector and regulatory officer for the FDA, he received several PHS Awards. He can easily draw from his experience in FDA compliance enforcement to speak to the issues in this case. IMS Reference #5009248

  • Pharmaceutical Chemistry

    This pharmaceutical chemistry expert specializes in pharmaceutical regulatory and compliance issues. He spent more than 25 years at the FDA, ultimately becoming a Deputy Director. While with the FDA, he was directly involved in many of the higher-profile FDA compliance and enforcement actions. He first joined the FDA as a review chemist in the Center for Drug Evaluation and Research, or CDER. He was directly involved with field inspection and compliance activities and worked with all FDA centers in the development of compliance programs, implementation policies and research efforts. He earned his B.S. in chemistry and his M.S. and Ph.D. in pharmaceutical chemistry. IMS Reference #5009324

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Industry: All, Pharmaceuticals