Accurate FDA Consultants President and Founder. Mr Feye is a recognized expert industry consultant and speaker. He has over 20 years of experience in Quality Assurance, Quality Control, and Regulatory Affairs. Mr. Feye has authored device, biologics and drug submission. He has assisted clients resolved over 20 Warning Letters.
Glen Feye, MS, and CQEAccurate FDA Consultants President and Founder
Mario Gemar, PhD.RA/QA Consultant
Dr Gemar has over twenty years Healthcare industry experience, including pharmaceuticals, medical devices and in- vitro diagnostics. Senior management experience in the areas of Quality System, validation, CAPA, design control, risk management and laboratory management.
Fifteen years industry experience in Quality Assurance, Quality Control, Auditing and Design Control
Experienced in US FDA and European regulatory body regulations; Lead Auditor for ISO 9001, ISO 13485, 21 CFR part 820, Part 210 and 21, GMP
Specific areas of expertise:
Biologics – Medical devices – IVDs – Regulatory Strategies for registration w/w
Medical Devices – Disposable/Drug device combination/ Implantable/IVDs Medical Devices – Active/Electronics/ IVDs/ Software/
Borderline cases of medical devices or medicinal products Others – Combination Products
Pharmaceuticals – API/Bulk Chemicals
Audits – Due Diligence/ GLP (Laboratory) / GMP (Pharmaceutical) / API / ISO /Quality System ISO – 13485/ 9001/Inspection Technique (QSIT)/ Quality System Regulation (QSR) / Supplier, Electronic Records & Electronic Signatures; 21 CFR Part 820, Part 11, FDA, GAMP, Hazard Analysis, ISO 14971 (Risk Management)/ Active Implantable Medical Device Directive (AIMD) / In-vitro Diagnostic Directive/ Medical Device Directive (MDD), Cosmetics Directive, ISO lead auditor, Quality Assurance, Quality Control, Quality Management, Quality Systems Development / Implementation, Regulatory Affairs, Training
Barney King, MD, MBAExecutive Regulatory and Clinical consultant
Dr. King is a highly talented Executive Regulatory and Clinical consultant. Dr. King is a recognized medical industry expert and has over 30 years experience in the Research and Development, Clinical and Regulatory Affairs in both the medical device and pharma industries. Dr. King’s regulatory and clinical affairs expertise includes developing regulatory and clinical strategies, interactions with FDA, and execution of the clinical protocols and studies.
Carol Cox-McClave MAExpert Medical Research Process Auditor
Ms Cox-McClave is an expert medical research process auditor, specializing in auditing computer systems. Provides both GCP and GLP services, auditing and training to pharmaceutical, biopharmaceutical, medical device companies, contract research organizations and academic institutions She also is an expert in Software QA.