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FDA Regulations, GMP/GLP/GCP Compliance; IND, NDA, BLA, PMA and Product Regulation; Toxicology
Experienced in all aspects of validation and compliance including, GMP/GLP/GCP and part 11. Expert worked for over five years as a reviewer of investigational new drug applications, marketing applications, developing guidance and government policy and supporting approval process. In addition,…
Offshore Advisory, Setting up Captive Offshore Centers, Managing Offshore Operations
His initial jobs were to do with Programming for EDP divisions, thereafter all through he has been involved in aspects of managing information at organizational level ranging from being responsible for planning and managing information management. All through his experience…
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…
Textile Flammability and Dyes, QC for Color, Textile Environmental, Training
Expert has over 25 years experience with bleaching textile materials composed of cotton, flax, wool, polyester and viscose on a full range of equipment including continuous steaming(roller and flatbed), jiggers, pad-batch, jets yarn package, skein and garment laundry. He is…
Plastics and Medical Device Development, Plastics Processing, Material, Tooling, Failure Analysis
Expert is a huge proponent of concurrent engineering practices. He has helped numerous companies by helping them implement principles of concurrent engineering which requires all the departments from marketing to manufacturing and assembly to work together right from the inception…
Boating Accident Investigation, Reconstruction, Search & Rescue, Navigation, Boating Safety, Rules
Applied Marine Technology, Inc. provides a full range of accident reconstruction services to his clients. We cover the gamut of vehicle accident reconstruction, as well as marine, aviation, and occupational/industrial accident reconstruction. From quick response to the accident scene, to…
Global Strategic Sourcing and Supply Chain Management; Cost Reduction; International Trade Dispute Resolution; New Product Development; U.S. Harmonized Tariff Schedule
Expert manages the global supply chain for a $200 million U.S. consumer goods company. Expert excels at solving complex and unusual international supply chain problems, particularly those involving suppliers in Asia, and especially in China. Expert speaks, reads, and writes…
Economic Damages and Lost Profits Calculations
Expert focuses on the calculation of economic damages. He prepares expert reports on lost earnings in personal injury, wrongful death, and employment matters, drafting expert reports, critiquing opposing experts and expert testimony in state and federal courts across the country.…
Software, Source Code, Programming, Patent, Copyright, Trade Secret, Music, Audio, Compression, MPEG, DSP, Signal Processing, Cell Phone, Camera, Game, Download, Streaming, Mobile, User Interface
Quick Overview: -Seasoned testifying expert witness with litigation experience (patent, copyright, trade secret, class action), skilled at explaining complex ideas to attorneys and juries. -Several decades of involvement in software, digital audio, digital music, digital signal processing, and processor architecture.…
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…