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Environmental Client & Project Management: Continuous Emissions Monitoring Systems (CEMS/CERMS)
Expert in Continuous Emissions Monitoring Systems for 30+ years, with experience with multiple instrument installations, testing, and certification for power plants, hazardous waste facilities. He is currently involved in ethylene oxide system installations and commissioning for sterilization plants. Principal Continuous…
Medical Device Design, Simulation and Development
Expert has 25 years of industrial experience in medical devices, consumer products, automotive, robotics, cutting tools and machine tools. He has helped companies to launch 200+ products, published several papers, patents, and chapters in books. His expertise is in medical…
Infection Control, Public Health, Employee Health, and SPD
Expert has over 5 years of experience as an Infection Preventionist in Acute and Subacute. Expert also has over 7 years of experience in medical instrument decontamination, sterilization and packaging. Skills: Completed HBX CORe (150-hour business certificate program). Management of…
Operating Room, Sterile Processing, and Surgical Practices
Experienced clinical leader with a successful record of leadership, experience and achievements advising medical device manufacturers, developing and implementing field-based sales/product training for sales reps, corporate clinical training, and continuing education workshops for medical/hospital staff and surgeons. Expert in Operating…
Sterile Processing Processes and Point of Use Care; Handling for Operating Room
Sterile Processing and Point of Use for Operating Room (SME) Expert is currently the Director of Development and Research. Ms. Expert has a notable combined 20 years of experience in Surgical Services as a cross-trained circulator/ surgical scrub and as…
Materials Engineering, Polymers, Metallurgy, Chemistry, Corrosion, and Adhesion Science
Expertise in chemistry, materials science, metals, polymers, corrosion, coatings and packaging. Expert has over 20 years of experience working as a technical consultant in materials engineering, polymers, metallurgy, chemistry, corrosion and adhesion science. She has been an advisor to companies…
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 Device & Pharmaceutical Quality Systems; Regulatory. Affairs; Quality Fitness Reviews
Advised and trained Operations and QA employees in a large pharmaceutical plant on effective practices to investigate and document deviation events on the manufacturing floor and quality control laboratory. The aim of such investigations was to determine a root cause…
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…
Medical Device Quality Assurance and Regulatory Compliance
Expert is a 34-year food, cosmetic, drug, biologic, clinical, medical device, and combination product non-technical quality assurance and regulatory compliance veteran with over 21 years of FDA/ governmental experience as an analyst and level II certified international medical device investigator…