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Pharmaceutical Quality Assurance
He possess thorough knowledge of GMP / GLP regulations like US FDA, WHO GMP, ICH, MHRA, ANVISA, requirements of cGMP documents (SOP’s/ Change controls/ Deviations) as per various regulatory agencies. He had actively participated in various international regulatory inspections (USFDA…
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…
Human Factors/Ergonomics, Systems Safety, Systems Engineering, Industrial Engineering, Design
Expert received his Bachelor of Science degree in Engineering (Astronautical) from Arizona State University in 1969. He next attended Central Missouri State University where he graduated in 1974 with a Master of Science degree with a field of specialization in…
HVAC Design and Manufacture
Expert evolved from a career in product design to manufacturing engineering. Several opportunities developed in start-up operations and relocation of total facilities. The largest task was the relocation of a Carrier Transicold plant from California to Georgia. This was a…
Grinding Processes and Technology, Power Tool Accessories Testing and Manufacture
52100 steel is the primary material used for standard bearings and automotive products that act as raceway materials. It is also common to use the material for bearing balls. The expert has extensive experience grinding the hardened form of this…
Pharmaceutical Manufacturing, Research and Development, Education & Training
Expert’s primary experience in tablet manufacturing covered conventional pharmaceutical tablets for a variety of drugs and chewable tablets of antibiotics, utilizing both dry and wet granulation techniques and a variety of processing and tablet equipment. His experience encompasses all aspects…
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…
ISO 9001-2000/TS 16949 audits, documentation, training, assistance for certification, APQP, SPC
Expert is an ISO 9000 Lead auditor. He has been implementing developed by ISO like ISO 9000, ISO 13485, and ISO 17025 for many years. He has assisted several companies from various industries to become certified from scratch. He has…
Quality Assurance Engineering
Expert has over 15 years of experience with quality assurance. He provided Quality Assurance support to insure timely and cost effective: systemic, design, component and product compliance. His activities included supporting: New Product Development, Design Reviews, Verification and Validation, Material…
Personal Injury, Industrial/Construction Safety, Compliance, Auditing, OSHA Standards
Expert provides safety engineering, accident investigation, accident reconstruction, industrial/construction accident consulting, expert witness testimony, and related expertise to a wide variety of clients. In addition to the automotive “Big Three” he was the safety director at a sheet metal stamping…