Carol Bognar is a Senior Director at The Weinberg Group. She has global responsibility for Good Clinical Practice (GCP) consulting services to Clients in the pharmaceutical, biotechnology and medical device industries and oversees the allocation of resources. She provides international project management and oversight for quality assurance audits to assess compliance with FDA Regulations, International Conference on Harmonization (ICH) Guidelines and other regulatory agencies. She has extensive expertise in Quality Assurance Services including the performance of over 300 GCP audits and has over 25 years experience in healthcare, beginning as a Registered Nurse. Most recently, Carol led a global team of auditors on a 5-year, 500 international audit program in 30 countries. Her international experience includes consulting and auditing in Latin America, Australia, South Africa, Europe and Canada. She has customized GCP, ICH and FDA training presentations and provided quality assurance consultation services, as well as SOP development, review and gap analysis. Her therapeutic experience includes managing and performing a wide range of audit programs in diverse areas including Analgesia, Arthritis, Cardiovascular, Central Nervous System, Critical Care, Endocrine, Gastrointestinal, Infectious Disease, Neurology, Nutrition, Oncology, Ophthalmology, Psychiatry, Pulmonary, Transplantation, and Wound-healing. In addition to investigator site audit experience, her experience includes conducting database, data management, system, CRO, IRB, clinical study report, vendor, and device audits.
She received her M.S. in Nursing from the University of Virginia, and a B.S. in Nursing from James Madison University.