Louie Goryoka

Full Name for Training Certificates: Louie Goryoka

Job Title: Consultant RA/QA

Company/Organization: Med-Device Consulting, Inc.

Years in Industry: 30

Bio: • Implement appropriate Medical, Pharmaceutical, Cosmetics Quality Management Systems • Auditing (FDA and ISO Compliances) • Audit Suppliers within the US, EU, and Asia for ISO, QSR and cGMP compliance as part of Supplier Evaluation and during Mock Pre-Approval Inspections (PAI).Outstanding US FDA Relationships and Negotiations. E.U./Global Regulatory Product Approvals. Facility Registration USA and Global • Establish Employee Training Program/Trained on various compliance programs QSR/ISO/GMP/GDP/CAPA/FMEA topics; Such as Good Manufacturing and ISO programs, Data Integrity, Good Documentation Practices, Lab Notebook Usage & Control, Technical Report Writing. • Remains current with regulatory with applicable elements of ICH Q10, FDA QSR, MDSAP and ISO 13485:2016, intelligence to ensures compliance and submissions are aligned with current standards/expectations and maintained up-to-date knowledge and understanding to implement appropriate Medical and Pharmaceutical Quality Management Systems in accordance with applicable elements of ICH Q10, FDA QSR, ISO 13485, eMDR and MDSAP for companies. Support Class I, II and III (PMA) Medical Devices, IVD Devices, Software Products, Drug/Device Combination Products, Pharmaceutical Products, Companion Diagnostics, Nutritional/Dietary Supplements, OTC Products and Laboratory Developed Tests. • Harmonize Deviation Reporting, Quality/QC using Track-Wise. Trained employees to perform investigations using FMEA. Establish procedures for CAPA and Root Cause Analysis using a risk-based approach. • Draft product Usability and RMF's files in compliance with the applicable standards (ISO 14971, IEC 60601-1, Third Edition, and IEC 60601-1, edition 3.1, 2012). • Support in quality and regulatory systems for clients to gain FDA approval (PMA) for Class III implantable IOL devices • Eliminate backlog of complaints • Warning Letter Remediation. Certified Lead Auditor – ISO 13485:2003, ISO 13485:2016, ISO 9000, MDSAP & TQM Management; Certified 5S program

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