Principle Consultant, ARC Verification, Parrish, FL, USA
20+ years of experience in:
• Manufacturing Process Controls: IQ, OQ, PQ, Protocols, Records and Reports for objective evidence of compliance to QMS requirements.
•Development, and Implementation, of Quality Management Systems i.e., US Government (FDA), EU and ISO 13485, ISO 22716, ISO 15378, EFfCI, EXCiPACT, 21 CFR’s, ICH Q7-10, cGMP’s and EU GMP
•Knowledge and Application of European, Japanese, Canadian, FDA Regulatory Requirements for Medical Devices, Cosmetics, and Pharmaceuticals and Cannabis •Strategic Planning, Proceduralized Manufacturing and Process Control Activities
•Supplier Quality & Manufacturing Process Improvement for Higher Yields
•Product & Process Validation & Verification to Assure Regulatory Compliance to FDA and Other International Regulatory Oversight Bodies Regulations for Product Quality, Safety and Efficiency
•Supplier Product (Materials) Quality Assurance & Performance Assessment