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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…
Clinical Trial, Biomarker, Clinical Development, Drug Safety, Medical Affairs, Commercialization
As a prescribing physician and a physician in drug development for many years, Expert has expertise in drug mechanism of action and clinical data, and clinical use. Expert is an expert in drug clinical development from planning to protocol design,…
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…
Agronomy, Regulated (GMO) & Regulated Crop/Seed Production, Management, USA, International shipments
Expert's experience in agricultural development includes introduction of center pivot irrigation for irrigated corn to western Nebraska in the early 1970's when the area had previously been considered only as a dry land wheat production land. He also worked in…
Marketing and Product Development of Raw Materials for the Cosmetics Market
30 years of experience working in the cosmetics industry as a raw material supplier. Long time member of the Society of Cosmetics Chemists. Developed and marketed new hydrophilic polymers for the cosmetics industry while working for BF Goodrich as the…
Agriculture, Horticulture, Loss Management
A successful twenty eight year career in agricultural chemicals involving retail management, field sales and product development roles. Industry experience with commercial, technical, research and practical hands on experience in a wide range of horticultural and agricultural crops has provided…
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…
Data Storage Technology, Data Storage Industry, Hard Disk Drives, Optical Drives, Solid State Drives
Expert has extensive experience in the field of disk drives, including substantial contributions to a number of very innovative and successful products and processes. These have included some of the industry’s earliest magnetoresistive (“MR”) head drives, Maxtor’s first double-capacity drive,…
Computers, Software, Hard Disk, Bus, Internet, Firmware, Input/Output, Technology Management
Expert is a technical leader in the computer, software and hard disk industry with over thirty years experience; his Ph.D. in Computer Science is from Stanford University. He is an inventor on seven patents and has authored several published technical…
Electronics, Software, Sensors, Motion Control, Wireless, and Medical Devices
Expert and his senior team have many years of experience designing embedded circuits, instruments, medical devices, and software. Expert in all types of measurements. Analog circuit design, digital circuit design, and mixed signal design, as well as measurement and control…