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
Dilip Ashtekar, Ph.D.
Dr. Ashtekar is a results oriented collaborative and Industry recognized expert leader in Pharmaceutical Microbiology, Sterility Assurance and Sterile product manufacturing with over 33 years of successful proven record of handling increasing responsibilities in leading Pharmaceuticals small molecule, Biotechnology (monoclonal antibodies), Biologically derived (microbial fermentation processes) protein therapeutics, Cell therapy, and plasma fractionation and plasma based products, Device and Vaccine industries. He is a member of United States Pharmacopeia (USP) Council for Expert Microbiology Committee (2010-Current). In addition, he serves as one of the key experts several Parenteral Drug Association (PDA) task forces and authored several Technical Reports (Environmental Monitoring TR 13, Mycoplasma Clearance by Filtration and Rapid Microbiology Methods, TR 33). He also served as lead member on International Society for Pharmaceutical Engineering (ISPE) Data Integrity Task Force.
He has extensive experience with Sterility Assurance, Quality System, Quality Culture, Data Integrity and sterile Drug Manufacturing, Aseptic Processing, Aseptically Filled products and devices, Radiation and Terminally Sterilized products by moist heat.
For the full bio and resume please see this link: http://accuratefdaconsulting.com/?page_id=478
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.
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
Sebastian Feye, BSCRA Manager
Sebastian manages Accurate Consultants Inc ongoing consulting projects with a focus on client contracts, project management, IT and finance/accounting. Sebastian oversees and submits regulatory submissions for client projects in both the US and rest of the world and is the day-to-day liaison between clients, consultants and FDA/Regulatory Authorities. Sebastian’s previous finance, risk management and team planning experiences with both PayPal, Norton and Symantec in Silicon Valley, CA are an asset to the successful completion of regulatory projects.