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Expert in Pharmaceutical Science; Preformulation, 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…
Expert in OBGYN; Obstetrics, Gynecology, & Reproductive Sciences
Expert is board certified in Obstetrics and Gynecology with over 10 years of clinical practice. She is experienced in medical records review and case merit analysis and also provides medical expert testimony. She is an experienced clinician currently in academic…
Expert in Sterile Processing Technology
ExpertKai Expert's formal training and industrial experience have provided him a solid foundation to design optimal heat sterilization processes for foods, pharmaceuticals, devices, biologics, and equipment. His activities in this field include low-acid canned foods, in-container or terminal heat sterilization…
Expert in Pharmaceutics
Expert is a process and chemical engineer with a Bachelor from Univercity Laval in Quebec City. He has more than 15 years experience in engineering, automation, validation of manufacturing equipments, clean utilities, pharmaceutical systems and computer systems (cGMP, GAMP5, CFR-21…
Expert in Pressure-Sensitive Tapes: Markets, Materials, Products, Processes, and Equipment
Expert has over 25 years' experience in the pressure-sensitive tape business. His experience includes operations management, and he has held COO and Senior VP titles alike. His total manufacturing experience spans over 40 years. Expert has devoted his career, respectively,…
Expert in Open Innovation, New Product Development, Intellectual Property Management, Technology Strategy
Experienced leader of new product development, technology strategy and development, open innovation, alliance management, licensing, deal structuring and negotiation, intellectual asset management, competitive intelligence, consumer and sensory science. Proven results based on sound business and technical judgement and excellent relationship…
Expert in Quality Assurance, Regulatory Affairs, and New Product Development Consultant
BS Engineering, 30+ years in senior technical/management positions in Quality Assurance, Regulatory Affairs, and New Product Development space. Expert in medical device, in-vitro diagnostic, and pharmaceutical products and processes. Core competencies in Design Control, Risk Management, Validation and Verification, and…
Expert in QC/QA, Sterility Assurance, Aseptic, Pharmaceutical, Biotech, Device Manufacturing & Testing
Environmental Monitoring Operations, EM Trends Reports, EM Remediation and Investigation. Cleanroom Contamination Control Practices, Behaviors, Personnel, Gowning, Cleanroom Traffic Guidelines, Process/Personnel and Product Flows. Microbiology Release Testing-Bioburden, Sterility Test, Growth Promotion, Materials Control, Microbial Identification, Bacteria Endotoxin, Biological Indicators Testing,…
Expert in Reproductive Medicine; Infertility, Reproductive Endocrinology
Expert J. Expert's residency training in Obstetrics and Gynecology was performed at The Stamford Hospital in Stamford, Connecticut. He then went on to complete his Postgraduate Fellowship in Reproductive Endocrinology and Infertility at The UCSD School of Medicine, San Diego,…
Expert in Gynecology, Minimally Invasive Surgery, Laparoscopy, Office surgery
Expert has pioneered many minimally invasive approaches to gynecologic surgical procedures in his region of Georgia. Having performed thousands of gynecologic surgical procedures, he has a broad range of expertise in laparoscopic, hysteroscopic, and vaginal approaches to gynecologic surgery. He…