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Practical Application of GLP, GCP, and cGMP to Pharmaceutical, Device, and Biotechnology Firms
As Vice President at a pharmaceutical company, Expert formulated eight pharmaceuticals for use in their patented buccal delivery platform technology. Five formulations were acceptable to FDA and were allowed to proceed into human clinical trials under IND controls. Four of…
Sterilization; Food & Drug Product, Packaging & Process Development; HACCP & Validation
Expert is a nationally recognized expert in aseptic, retort and autoclave, thermal processing and associated packaging of foods and drugs. He is well networked with the FDA food regulatory agency technical staff, academia, other process authorities, and research consortia. He…
Cardiothoracic Surgery, ECMO, SWOG, CPB, Ischemic and Valvular Heart Disease, Esophageal Cancer
EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO). Expert is an ECMO Program Director and has extensive experience with neonates, pediatric, and adult patient management. He has a longstanding interest in venovenous gas exchange. He helped develop the double lumen venovenous cannula. He is…
Food Protection: Defense & Safety: Sorbic Acid; Microbial Quality, HACCP, FDA FSMA
Expert has devoted a major portion of his career to research and teaching related to food safety issues, especially food microbiology. A special emphasis has been directed at new and traditional preservation techniques and how their modification and application influence…
Construction & Mining, Cranes, Rigging, Litigation Support
Expert has extensive experience in the construction and mining industries as a Supervisor, Manager, Estimator and Safety Professional. He understands how to develop and set up a safe project, and can help to keep it on budget and schedule through…
Bioprocessing & Biopharma
Expert has 13+ years of experience in Biopharma and Bioprocessing, with R&D, MSAT and manufacturing experience. He is well versed in process development, scale-up to manufacturing, GMP manufacturing, and FDA-approved manufacturing facilities as both a client and customer. He can…
Software & Technology: Product, Commercialization, M&A Strategy, Expert Witness
Expert stands out as a distinguished Senior Executive and Board Director, renowned for his transformative approach in product and commercial strategy. His dynamic leadership has been pivotal in accelerating growth, enhancing customer trust, and successfully turning around struggling ventures. Expert’s…
Critical Care Nursing: Neurology, Stroke, Cardiology, Emergency Services, Palliative:Hospice Care, and Quality.
Expert is an experienced critical care Registered Nurse and Public Health Nurse with a demonstrated history in Neuroscience, Stroke (SCRN), Cardiology, Interventional Neurology, Critical care, Nursing Leadership, Interventional Cardiology, Microsoft Suite, Certified Death Doula, Triage, Advanced Cardiac Life Support (ACLS),…
Valuation Analysis & Forensic Accounting: Divorce, Bankruptcy, Fraud, Partnership Disputes, and Economic Damages
Expert is a forensic accountant and valuation analyst experienced in assisting with matters involving divorce, bankruptcy, fraud, partnership disputes, and economic damages. He performs business valuations for litigation matters, transaction planning, employee stock ownership plans, and estate and gift tax…
Telecommunications and CCO Leadership
Expert is a qualified, persuasive and influential C-Level professional offering over 20 years' in-depth experience. His professional breadth includes international exposure and year-on-year success in achieving revenue and business growth objectives within prestigious organizations. Throughout his successful career, Expert has…