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HVAC Design, DDC Control, Fluid Dynamics, Constructability
He has over 30 years experience in the design, installation and service of all type of air conditioning systems including DX, centrifugal and absorption machines. He possess EPA Universal Certification to purchase and use freon type refrigerants He has the…
Aeronautics, Flight Training, Air Traffic Management
Expert has been in the Aerospace industry for over 20 years. His experience includes flight instruction, courseware and CBT development, simulator validation, fleet management, aerial firefighting and operational expertise for Airlines and Training Organizations. Expert has applied his aeronautical expertise…
Quality by Design, Good Laboratory Practices, Intellectual Property Security, ICH and FDA Compliance
As the former CIO of a Fortune 50 product development and commercialization subsidiary, and the executive tasked with building an ISO compliant records management program, Expert has had more than 15 years of experience planning, developing, implementing and then managing…
Analytical Chemistry, Analytical Technology Development and Application
Expert is a Ph.D. Pharmaceutical Analytical Chemist with extensive experience in separations (LC, GC, Prep GC), dissolution, automation (robotics, computers) and general analytical technologies. He has familiarity with NDA programs and marketed product support, including analytical method development, process support,…
Adhesives for Medical Device, Biotech, Pharmaceuticals, Aerospace, Materials Science, QA, QC
With a PhD in organic chemistry expert has spent over 25 years developing adhesives, resins and advanced composites for a variety of applications. He started at the bench chemist level and worked his way up into R&D management. Some of…
PK/PD Modeling and Simulation; Nonclinical and Preclinical Statistics; Experimental Design
He managed group of 5 biostatisticians working on Phase I and PK/PD trials. His responsibilities included protocol design, statistical analysis plan writing, specification writing, and delivery of product to customers. He was responsible for meeting all timelines and budgets, assuring…
Aseptic Process Design, Airflow Visualization, HACCP, PAI Preparation, Cleaning Validation
Expert has performed validation of aseptic processes including technologies such as blow-fill-seal, high-speed automated liquid and powder filling lines, lyophilization, barrier and isolation technology, and bulk pharmaceutical and biological processes. Expert has developed an airflow visualization procedure to assist the…
Engineering Management
Expert has been involved with the re-engineering of new product development processes, creation of total quality management programs, and organizational structure changes for process engineering and research and development functions for two major medical device manufacturers (i.e. Johnson & Johnson…
Near-Infrared Spectroscopy, Statistics, Chemometrics, and Software Development
Expert has expertise in the design and development of spectroscopic instrumentation, particularly in the near-infrared spectral region. He was on the design team for several of the instruments produced by a major manufacturer. He was the chief system troubleshooter, integrating…
Software Quality & Life Cycle, ISO 9000 Standards, Software Regulatory Issues, etc.
Ms. D. Expert has extensive expertise with the maintenance, re-engineering, and reuse of computer software. She has maintained large telecommunications systems and established processes that resulted in effective provision of service to company engineers. She was the Chair of a…