2 Fda Quality System Expert Witnesses Found

Results Sorted Below by State

J. Lawrence Stevens, RAC ONE WAY CONSULTANTS. LLC, FDA Regulatory Experts

East Alton, Illinois
Medical Devices, Biomedical Engineering - FDA, Medical Devices, FDA Compliance, FDA law, FDA Inspections, FDA medical device regulation, FDA medical device labeling, FDA regulation of clinical trials, FDA approval of medical devices. Medical Device Recalls, Medical Device Complaints, FDA Inspections
A recognized expert on the FDA regulation of Medical Devices. Experience as an expert witness involving medical device firms and FDA requirements regarding approvals, recalls, complaint investigations, and labeling. Over 20 years of FDA experience encompassing virtually all of the FDA field positions. Also eighteen years of industry experience as a mid-level manager and senior executive in clinical, regulatory, and quality in the medical device industry. Personally designed quality systems, prepared regulatory submissions (510(k), IDE and PMA) and managed 7 multi-center clinical trials for class 3 medical devices. From 1989-1993, was the Industry Representative on the FDA Circulatory Systems panel which reviewed over 30 PMA clinical studies for cardiovascular device. Serve as an expert witness for cases involving FDA regulation compliance for medical devices. Regularly perform webinars regarding FDA and issues regarding clinical studies and medical devices....

Shaun R Opie, PhD E4 Bioscience

Charlevoix, Michigan
Cannabis, Laboratories & Testing - Laboratory, Cannabis, Marijuana, Compliance, Regulatory, Cannabinoid, THC, Potency, Contaminant, Quality Management System, Audit, ISO 17025, FDA, Clinical, DNA, Molecular, Genetic, Testing
...Since 2018 he has been advising laboratory owners and investors about regulatory, quality, scientific, and business operations issues. In addition to being a regular invited speaker at national conferences, He is also the editor and contributing author to the textbook, "Cannabis Laboratory Fundamentals". Dr.Opie has written a variety of articles around laboratory operations including: Cannabis Laboratory Planning, Design, Licensing, Instrumentation, and Staffing, A Hemp Growers Guide to Compliance Testing for THC and CBD Levels, A Guide to Preparing Cannabis Laboratory Business License Applications, and How to Start a Cannabis Testing Lab: A Step-by-Step Guide. Dr. Opie is a quality management system lead assessor for laboratories pursuing ISO/IEC 17025:2015 accreditation.