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Root Cause Analysis, Problem Solving, SPC, Design of Experiments, Six Sigma
Expert has been a member of ASQ for 20 years. He has been a senior member of ASQ for 10 years. He has served as the Examining Chair for the Indianapolis Section of ASQ for 15 years. Through his work…
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…
Process Engineering and Chemistry of Inorganic Chemicals
Expert W. Expert has 20 years’ experience in process design and operation of chlorine manufacturing facilities. He has worked on projects including the development of material and energy balances and the equipment sizing for a 15% chlorine plant expansion, troubleshooting…
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…
Contamination Control and Cleanrooms
The relationship between facility cleanliness and product cleanliness, between design criteria and operational conditions is one that even today oftentimes remains a mystery. Particle fallout is the source of visible contamination for contamination sensitive products during storage and assembly. While…
Sterilization; Food & Drug Product, Packaging & Process Development; HACCP & Validation
Expert is a nationally recognized expert in aseptic, retort and autoclave, thermal processing and associated packaging of foods and drugs. He is well networked with the FDA food regulatory agency technical staff, academia, other process authorities, and research consortia. He…
Design of Experiments, Reliability, Quality, Accelerated Life Testing, Probability and Statistics
Expert (rhymes with "hats off") has designed state of the art reliability and accelerated life testing software that is used throughout IBM. This software is incorporated within IBM's AGSS system, an interactive statistical graphics system that has been marketed by…
Design for Manufacturability, Mass Customization, Build-to-Order, Concurrent Engineering
Expert is a const reduction expert that helps companies reduce cost as much as half the total cost through product development and cost savings through on-demand production and spontaneous (pull based) supply chains. He has developed leading-edge methodologies that show…
Process Control, Systems, and Optimization
Most recently Expert’s work has centered on pharmaceutical batch processes requiring Food and Drug Administration (FDA) software and hardware validation. Expert notes that generally, this requires a data model (both procedural and physical) following the guidelines of ANSI/ISA S88.00.02 and…
Total Quality Management
QUALITY; QUALITY CONTROL; QUALITY ASSURANCE. Expert has spent a significant portion of his career in the area of quality, quality control, and quality assurance. He has been a Quality Assurance Manager for three different industries since 1984. As such, he…