Overview: his webinar is intended to help you get familiar with current Good Manufacturing Practice (cGMP) requirements for medical devices including IVDs. This webinar is further intended to provide guidance on implementing the cGMP requirements as set forth in the FDA Quality System Regulations (QSRs), which help assure that medical devices are safe and effective for their intended use. Adequate interpretation and implementation of cGMP requirements compliant with FDA QSRs can significantly contribute to achieving compliance fast, resulting in saving significant amount of unnecessary time and efforts and, thereby bringing innovative medical products to the market faster. This webinar will discuss Quality System (QS) regulations, requirements and how to achieve compliance. This webinar will help you profoundly change your way of executing your regulatory and quality compliance projects in an efficient and effective manner. Why Should You Attend: This webinar will help you establish and maintain medical device quality management system requirements compliant with FDA quality system regulations (QSRs; also known as cGMPs). Areas Covered in the Session: Overview and review of the US QSRs for medical devices Flexibility of the QSRs Definitions Quality system requirements Management responsibility Audits Personnel Design control: design and development planning, design input, design output, design review, design verification, design validation, design transfer, and design changes Design history file (DHF) Device master record (DMR) Quality system procedures Purchasing controls Inspection, measuring and test equipment Process validation Corrective and preventive action (CAPA) Complaint files Servicing Quality requirements for premarket approval (PMA) application Enforcement actions: case studies Lessons learned Who Will Benefit: Regulatory Affairs Managers, Directors and VPs Clinical Affairs Managers, Directors and VPs Quality Managers, Directors and VPs Quality Managers, Directors and VPs Compliance Managers and Directors Sales and Marketing Managers, Directors, and VPs Complaint Handling and Risk Management Managers and Directors Site Managers, Directors, and Consultants Senior and Executive Management Compliance Officers and Legal Counsel Business Development Managers, Directors, and VPs Dr. Lim obtained his Ph.D. in biological sciences at the University of Missouri-Columbia and published his thesis research in the prestigious journal “Science.” Since then, Dr. Lim has held various positions at Duke, US National Laboratories, Intrexon Corporation, Terumo, US FDA/CDRH, and EraGen Biosciences, Inc., A Luminex Company. Price: $225.00 USA GlobalCompliancePanel, Livermore Common, Fremont, CA, 94539 USA Phone:800-447-9407 Fax: 302-288-6884 webinars@globalcompliancepanel.com http://www.globalcompliancepanel.com