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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…
Process Automation: Process Control, Computer System Validation, Alarm Management, & Modeling
Expert served for several years as a major pharmaceutical company's chief Quality Assurance GMP/GLP computer validation auditor. He chaired the team that developed the company's first policy and guidelines regarding computer validation,- and served for several years as the company's…
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…
Disposable Hygiene Products, Manufacturing, Quality, Product Development and Cost Analysis
Expert has applied his quality management background to set up “acceptable quality standards” in many companies and industries as well. He has selected alternative tools and systems to match with the needs of the environment as well the level of…
Professional QA & Regulatory Compliance for Medical Devices, Plastics Process Qualification
Expert has over 30 years of experience as a quality improvement professional, providing technical and managerial quality systems management. His base is a select group of processes within which we maintain current knowledge and process engineering skills. He offers full…
ISO 14001 EMS Implementation, Auditing, and Tailored Training; Integration with GRI Reporting
As a former member of TC 207 and former accredited EMS auditor, as well as an instructor of several accredited ISO 14001 Lead Auditor course providers, he was involved with ISO 14001 since the early 1990's - by way of…
Supplier Quality Assurance, Cost Improvement Projects, ISO 9001:2000 Quality Systems Management
- Expert audited suppliers to conformance with expected standards, such as TS 16949:2002 or ISO 9001:2000. An ISO standards based checklist was used; this provided quantitative scores for each category. Objective evidence and comments were compiled as the audits progressed.…
Fastener Engineering, Fastener Failure Analysis, Fastener Quality Evaluation, Forensic Analysis.
Expert specializes in: Fastener Failure Analysis, Training, Operations Improvement, Quality Systems and Continuous Improvements, Technical Marketing, Cost Reductions, Fastener Deproliferation, ISO 9000 and Product Manual Preparation and Updating, Customer Satisfaction Metrics and Analysis, Process Mapping and Root Cause Analysis, Calculating…
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 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…