Kevin takes a practical approach which allows scientists to assess risk with limited data sets. He is effective in facilitating team discussions to document current state product and process understanding.
Dalfoni Banerjee is an award-winning, solution-focused entrepreneur. Beginning her career over 25 years ago in academic, pharmaceutical, and biotechnology research laboratories, she went on to lead inspection-readiness efforts, drive clinical research and clinical operations, manage relationships between pharma and key opinion leaders, develop marketing strategies/tactics, and launch new drug products – across 12+ therapeutic categories
Expert in process improvement, metrics, and root cause analysis in clinical trials
Brooke L. Casselberry
Brooke Casselberry is the founder of Cyan Life Sciences, providing consulting services across the regulatory product lifecycle. Brooke’s experienced in developing regulatory domains, expanding business, and supporting clients in knowledge exchange, technology procurement and support, project management, and methodology development.
Natalee received her Nursing Degree from Union University and has practiced in the areas of Intensive Care and Surgery. She has a background in Sales and Sales Management in Home Infusion, Capital Equipment, Surgical devices and Biologicals.
Jerry Chapman is a GMP consultant with nearly 40 years of experience in the pharmaceutical industry.
Greg Martin is President of Complectors Consulting (www.complectors.com) which provides consulting and training in the area of Pharmaceutical Analytical Chemistry. Mr. Martin has over 25 years experience in the pharmaceutical industry and was Director of Pharmaceutical Analytical Chemistry (R&D) for a major PhRMA company for a number of years.
Lisa Olson has over 30 years of experience in FDA-regulated industry, with a major pharmaceutical company, three CROs, and in consulting roles. With a background in system development and support of clinical research systems, she developed her career into regulatory compliance of computer systems and a specialization in 21 CFR Part 11.
Luisa Monica’s experience includes oversight of electronic TMF (eTMF) implementation, quality control, coordination of migration projects, facilitated training programs, enhancement and development of TMF processes, and extensive inspection readiness preparation for FDA and MHRA inspections.
Jackie Morrill’s experience includes oversight of electronic TMF (eTMF) implementation, coordination of a large migration and integration projects, development of robust metrics and training programs, enhancement and development of TMF processes, and extensive inspection readiness preparation for FDA, MHRA, and PDMA inspections.