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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…
ISO 9001:2008 for plastic industry, Plastic Molding Processes, Metal Injection Molding process; Elec
He is RAB certified Lead Auditor for ISO-9001:2000:2008 since 1994, with second and third party auditing experience; He trained clients for ISO 9001:2008 QMS certifications and taught CMQOE (Certified Quality Manager’s) course through ASQ and Internal Auditor courses, and ISO…
Analytical Chemistry, Environmental Chemistry, QA/QC, GC-MS Data Analysis, Legal Defense
Expert has provided professional services in chemistry for over 40 years to government agencies and private industry, including legal firms. His commitment to careful, detailed, and documented work results in clients that rely on him to ensure that their legal…
Program Management, Quality Systems, Strategic Improvement Initiatives, Quality Assurance
During the 20 years professional life, Expert held a variety of global positions of increasing responsibility in all aspects of program and quality management including Portfolio management, New Product Introduction program management, Strategic Planning, Development on new product introduction methodology,…
Pharmaceutical Quality Assurance, Quality Control, Supplier Selection and Supplier Quality
Expert has extensive expertise in GMP matters in the pharmaceutical and medical device industries. During his 20 years in industry, he devised, managed and led programs to assure compliance to drug GMPs, GLPs and GCPs. Key areas of expertise included…
Nursing Care and Rehabilitation
Expert is a highly respected independent independent nursing, care and rehabilitation expert. She has worked in this field for over 13 years and provided opinion on a large number of cases (over 1000) worldwide. Expert is experienced in the following…
Implementation and maintenance of Quality Management Systems, Pharmaceutical GMP for Excipients
Expert has applied his scientific background in various companies over the past 25 years. He has set up and managed spectrophotometric and electron microscopy laboratories - choosing and installing (including EDX and WDX analysers), undertaking research and developing a range…
Development and Assurance of High-Assurance / Safety-Critical Software & Embedded Systems
Expert has substantial experience with software safety and reliability. Most of his career has been spent working with high-assurance systems and safety-critical software. He has developed software for commercial aviation systems, for medical devices, and for industrial controls and safety…
Food Chemistry, Sensory Evaluation, Food Microbiology, Laboratories Accreditation, Quality Systems
Expert has several years of professional experience in Food Analysis, Food Chemistry, Food Microbiology, Quality Assurance of Food Microbiological and Chemical Laboratories, Quality Assurance of Mycotoxins Analysis Laboratories, Quality Assurance of Sensory Analysis Laboratories, including extensive work in application of…
Environmental Chemical Analysis, Quality Assurance And Control
Expert has 15 years of experience in the pesticide residue and environmental analytical laboratory industry. He was responsible for Quality Assurance and quality control, including Environmental Laboratory Certification and Accreditation interacting with Federal and State agencies. He has written and…