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FDA Compliance, Project Management, New Product Development, Validation, Cultural Transformation
Expert has audited many cGMP operations. A good audit starts with a good plan. Before starting an on-site audit, he reviews past audits. He notes indications of possible problem areas and items, if any, that were identified for corrective action…
Steam and Power Plant Engineering, Economics, Operation, and Design; Boilers and Boiler Rooms
Expert began training on marine boilers in 1978 as a cadet at the Massachusetts Maritime Academy. He added experience as an operator of stationary fire tube and water tube boilers around Boston. Expert's 20+ years of employment with the Navy…
Operational Streamlining, Organizational Transformation, Program Management, and Technology Integration
Expert has extensive experience in Software Project Management of over 20 years in federal and commercial sectors. He has managed projects involving application development, system integration that required integration of commercial software products (COTS) with application code, software conversion, and…
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…
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.…
Analytical Chemistry, Analytical Technology Development and Application
Expert is a Ph.D. Pharmaceutical Analytical Chemist with extensive experience in separations (LC, GC, Prep GC), dissolution, automation (robotics, computers) and general analytical technologies. He has familiarity with NDA programs and marketed product support, including analytical method development, process support,…
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,…
Industrial Hygiene, Occupational Health, Hazardous Materials Management, Emergency Response
He championed the implementation of a variety of strategies to reduce workplace accidents and injuries. Strategies included establishment of on site workplace health and safety teams. These teams included both management and labor employees who worked together to identify safety…
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…