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Pharmaceutical Science; Preformulating, Development, Chemistry, Manufacturing & Control (CMC) Issues; Paragraph IV Hatch-Waxman & Canadian Notice of Allegation
As the development of a pharmaceutical reaches Phase 3, prior to submission of an NDA, method validation is required. Validation is a demonstration of optimization. By demonstrating the capacity of a method within the bounds of validation, optimal conditions for…
Medical Director Jails and Prisons and Covid-19 consultant across U.S.
Expert has been the Medical Director of Jails and Prison inmates for 20+ years. He is a COVID-19 consultant for Group Homes and schools for troubled youths, Juvenile Jails and ICE facilities. He is currently defending many jails and prisons…
Medical Excellence- Management (Preauthorization/ Reimbursement)
An astute and skilled professional with over 7 years of experience in the field of healthcare operations. - Currently serving as Medical Excellence Manager; qualified MBBS, Lean Six Sigma Black Belt from Michigan institute and Gold Medalist in MSc Healthcare…
Organic Chemistry, Chemical Engineering and Material Science
Expert has over 25 years of industrial experience in a variety of areas ranging from chemical synthesis, pharmaceutical chemistry, sensors, light to energy conversion, membranes, nanotechnology, security technology, analytical methods, chemical additives, combinatorial chemistry and process separation technologies. Expert is…
Pharmaceuticals
PROFESSIONAL EXPERIENCE: Development, implementation and monitoring of clinical pharmacy services consistent with current practice guidelines for the following units: Neonatal Intensive Care, Pediatric Oncology, Pediatric Surgery, Pediatric Emergency Medicine, General Pediatrics, and Pediatric Intensive Care units. Formulary management and drug…
Pediatric Hospital Medicine
I am an experienced pediatric hospitalist (20 yrs) with 5 years of legal consultation experience for both plaintiff and defense. I am finishing a fellowship in Medical Genetics and Genomics this August.
Nursing
As experienced nurse who has worked in two different hospitals over the last nine years, Experthave seen many medical errors being made in a healthcare-delivery system that seems unwilling, or unable, to change. He has seen patients getting the wrong…
Sterile Compounding, USP 797/795/800, Home Infusion, TJC/ACHC/BOP Regulations, Healthcare/Change/Project Management, Acute/Hospital Pharmacy Management, Pharmacy Automation, Mail Order Pharmacy, DME
Expert is an experienced PharmD, Director of Pharmacy and Assistant Clinical Professor with 6 years of experience at small, medium, large, level 1 trauma academic, acute care and long-term acute care hospitals. She has deep experience in pharmacy operations, finance,…
Clinical Development, Safety Reviews, Pharmacovigilance, Pharmacoeconomics
• Employer for preparation for an FDA Advisory Committee regarding review of an NDA. • Design and implementation of Phase I-IV clinical studies • Employer to many large pharmaceutical companies • Employer to Biotechnology companies and CROs • Medical safety…
Medical Device Accidents, Surgical Fires, Oxygen Safety, Medical Gas Piping, Failure Analysis
Eng. Expert has been conducting medical device accident investigations for 25 years and product failure analysis for more than 30 years. These failures sometimes involve the actual failure of a metal, plastic, or glass part or a failure of the…