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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…
Sterile Process Validation, Microbiology, Steam Sterilization, Aseptic Filling, Rapid Micro Methods
Expert has over 25 years experience in various aseptic of sterile process validation. She has worked for Baxter, Fujisawa (now Astellas), Jordan Pharmaceuticals, Vectech Pharmaceutical Consultants and Excellent Pharma Consulting. This encompasses steam sterilization, aseptic filling, process validation, development of…
HVAC and Refrigeration, Process Piping and Plumbing, Cleanroom Design, Hazard Occupancies, and Codes and Standards
Expert is principal and founder of a consulting LLC and is a consulting Mechanical Engineer specializing in the built environment; Expert provides: - Project Design and Management Consulting - Forensic Analysis and Litigation Consulting - Expert Testimony at Legal Proceedings…
CGMP,Pharmaceutical Manufacturing and Operational Excellence
Expert has over thirty (30) years of experience in the area of pharmaceutical manufacturing, pharmaceutical research and development, outsourcing, operational excellence and cGMP. Expert has broad ranging experience in pharmaceutical development, manufacturing and outsourcing that includes basic research in the…
Statistics (Pharmaceuticals (CMC): Design of Experiments, Process Validation, Stability)
After receiving a Expert in statistics, expert has worked in the pharmaceutical industry for over 30 years as a non-clinical statistician applying statistical methodologies, performing data analysis, and interpreting results with scientists in research and development. He collaborated with scientists…
Commissioning, Start-up and Validation of Biotechnology and Pharmaceutical Processes
Expert has over 30 years' experience in research, development, QA/QC, technical service, validation, manufacturing and engineering management. All of the above have taken place in the food, pharmaceutical and biotechnology industries. Expert has formal training in microbial physiology, biochemistry and…
Epoxy Floor Coat, Surfacing Systems and Moisture induced failures.
Expert has over 30 years in the development, introducing and placement of epoxy flooring and wall coating, with over 10,000,000 square feet in pharmaceutical industry alone. He has worked for Companies ranging in size from billions of dollar multi-national to…
Bulk Solids and Material Handling, Plant Design, Site Master-Planning and Project Management
Expert holds two patents for Powder Handling System; he invented a new instrument for measuring solids flow rate using a vision system with great accuracy. Expert draws upon 22 years of solid experience in powder and bulk solids handling where…
Motion Sensors, Occupancy Sensors, Passive Infrared, Analog, Digital, Electronics & Proposals
Degreed, self-starting Electrical Engineer (BEE) who specializes in digital and analog circuit and system design and hardware, firmware, and software development. Skilled in the design, invention, and innovation of high technology security electronics. Extensive background in digital circuitry enhanced with…
Food Process Engineering: Facility Design and Construction, Equipment and Process Design, and CIP
Expert is a registered, professional engineer with over twenty-five years of experience in food process engineering. He is an Associate Professor of Food Process Engineering. His responsibilities include technical assistance to entrepreneurs and food processors, research and development of food…