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Expert ID: 731924 Illinois, USA

Expert in 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…

Expert ID: 731889 California, USA

Expert in 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…

Expert ID: 731823 Pakistan

Expert in Foods, Home & Personal Care Product / Process Development, Supply Chain Operations, Quality & Safety Systems

Expert is an accomplished professional with extensive leadership experience with Unilever plc and as a management consultant with Compass Consulting. He has over 25-years’ track record of driving business growth by successful execution of value improvement programs across supply chain…

Expert ID: 730680 Illinois, USA

Expert in 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,…

Expert ID: 730278 Alabama, USA

Expert in Medical Device Sterilization, Medical Device QA, GMP Audit, Supplier Audit, SOP\’s

Expert, Consulting Principal, is highly regarded in the medical device and sterilization industries. Areas of expertise include: medical device sterilization (Radiation and EO), quality systems development and assessment, sterilization management, medical device regulations, supplier auditing, internal auditing, nonconformity investigation and…

Expert ID: 730258 California, USA

Expert in Medical Device Regulatory Affairs, Quality Assurance, FDA 820 EU ISO 13485 510(k) & Medical Software

Lead and developed regulatory plan and strategy for Molecular Diagnostic System. Blood Analyzer, Gene Profiling Reagents, Blood Analyzer etc. Assembled with team regulatory submission and obtained 510(k) clearance, EU CE Mark, Health Canada, China SFDA, Mexico, Australia, South Korea, and…

Expert ID: 729549 California, USA

Expert in 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…

Expert ID: 728217 Maryland, USA

Expert in QC/QA, Sterility Assurance, Aseptic, Pharmaceutical, Biotech, Device Manufacturing & Testing

Environmental Monitoring Operations, EM Trends Reports, EM Remediation and Investigation. Cleanroom Contamination Control Practices, Behaviors, Personnel, Gowning, Cleanroom Traffic Guidelines, Process/Personnel and Product Flows. Microbiology Release Testing-Bioburden, Sterility Test, Growth Promotion, Materials Control, Microbial Identification, Bacteria Endotoxin, Biological Indicators Testing,…

Expert ID: 727886 United Kingdom

Expert in International Standards – Quality, Environment, H&S, Business Continuity, Information Security

Expert has implemented a number of management systems around the globe for organisations looking to improve their business through standards. Having worked for the British Standards Institution for over 10 years and with now over 10 years consultancy he is…

Expert ID: 727843 South Africa

Expert in Apparel Productivity, Ethical Compliance and Quality Management in Underdeveloped Countries

Expert has thirty years experience in quality management starting when this discipline was in its infancy in 1981. Wrote and instituted the original standards and procedures for Gap and managed their US and Caribbean suppliers. Subsequent to that he worked…

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