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Medical Device & Pharmaceutical Quality Systems; Regulatory. Affairs; Quality Fitness Reviews
Advised and trained Operations and QA employees in a large pharmaceutical plant on effective practices to investigate and document deviation events on the manufacturing floor and quality control laboratory. The aim of such investigations was to determine a root cause…
Medical Device Quality Assurance and Regulatory Compliance
Expert is a 34-year food, cosmetic, drug, biologic, clinical, medical device, and combination product non-technical quality assurance and regulatory compliance veteran with over 21 years of FDA/ governmental experience as an analyst and level II certified international medical device investigator…
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…
Safety, Quality System and Energy Auditing
SAFETY Expert. Expert has successfully initiated and actively contributed to the following activities: * Chair of the Division Health and Safety committee. * Developed local Health and Safety management plan and practices * Developed and implemented Safety key performance leading…
Design & Development of High Tensile Fastener Process, ISO 9000 QMS, TPM – 5S Practices
Expert has 20 years of experience in ISO 9000 QMS and auditing practices. He started working in a fastener factory from 1969 to 2009 and is currently continuing as a consultant in the same company. This company was the first…
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…
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…
Chemical Engineering, Trouble Shooting of Chemical Plants, Fats & Oils, Biodiesel, Biofuels
Expert is a chemical engineer with master’s degree in Business Management. Expert has over 22 years of experience in large Oleo chemical oil refineries, petrochemicals and fertilizer industries in Asian countries. He has been involved in successful troubleshooting of various…
Quality Management Systems and Engineering Ceramics
Expert W. Expert has extensive experience with implementing and managing the ISO 9000 series of quality standards. He became an ISO Lead Auditor at Corning, Inc. He used his knowledge to implement and pass the ISO 9000 quality systems at…
Practical Application of GLP, GCP, and cGMP to Pharmaceutical, Device, and Biotechnology Firms
As Vice President at a pharmaceutical company, Expert formulated eight pharmaceuticals for use in their patented buccal delivery platform technology. Five formulations were acceptable to FDA and were allowed to proceed into human clinical trials under IND controls. Four of…