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 CQE
Accurate 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
Mario Gemar, PhD.
RA/QA ConsultantDr Gemar has over twenty years of 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 Controls, Auditing and Design Controls.
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, RAC
RA ManagerSebastian is a Regulatory Affairs specialist, RAC Devices Holder and project manager for medical device, IVD and combo drug-device projects. He communicates directly with FDA and serves as the liaison between clients and FDA. Sebastian has prepared and submitted successful EUA, Pre-Submissions, 510k, and IDE submissions for development of new medical devices. Sebastian also serves as project manager for various non-compliance projects, including 483 and Warning letter remediation projects and acts as a Quality Manager for a client. Has experience writing and running test protocols for medical device testing. Additionally, he manages FDA device and drug registration and listing for both domestic and international clients.
His LinkedIn can be found here: https://www.linkedin.com/in/sebastianfeye/