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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…
Safety, Ergonomics and Human Factors
Has provided workplace safety and injury reduction programs for several organizations including hospitals, industrial organizations and governmantal entities. Has investigated hundreds of product liability and personal injury accident cases in the area of human factors, safety, and industrial-organizational psychology. Issues…
Chemical Hazard Consulting, Environmental Compliance, Occupational Safety
He has applied his knowledge of employee chemical hazard communication to creating chemical labeling compliant with all world-wide regulations. Expert has extensive knowledge of chemical regulations pertaining to hazard communication in the US, Canada, EU, Japan, and other national requirements.…
Fire Origin & Cause- Fire/Building/Life Safety Codes-Fire Dept.Operation/Procedure- Spoliation Issue
Fire & Explosion Investigation Expert provides fire origin and cause investigations, fire consulting, and fire expert witness services throughout the United States and Canada. He is a Certified Fire Investigator with national and international certifications and have conducted thousands 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…
Protection Design, Testing, Data Analyses, EMP, EMC, COMSEC, ZONING, TEMPEST
The electromagnetic protection process is an evaluation of risk assessment against criteria (EMP, EMI/EMC, TEMPEST, EM-health). The entire process covers mainly: risk evaluation, design, construction, maintenance and testing. Starting from the risk evaluation, the different aspects of electromagnetic protection can…
Software Application Development, IT Compliance, Pharmaceuticals, Large systems Release Engineering
Expert has designed a number of customer relationship management solutions (CRM) using different platforms such as salesforce.com, salespharma.net. Also, in his capacity as a director of technology for a number of companies he has been involved in the technical evaluation,…
Forensic Electrical Electronic Engineering, Fire Investigations, Patent Infringement, Reverse Engineering, and Failure Analysis
Expert has worked in electronic forensics and patent infringement analysis. He specializes in all types of electronic devices, systems and products. Expert is a registered Electrical PE in the following states: North Carolina, South Carolina, Virginia, West Virginia, Tennessee, Georgia,…
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…