cGMPs for Medical Devices, Including In Vitro Diagnostic Devices

Why Should You Attend:

To achieve sustainability and to remain sustainable and competitive in medical device markets, it is necessary to establish and follow good manufacturing practices (cGMPs) set out in the quality system regulations (QSRs), which help assure that medical devices are safe and effective for their intended use.

Understanding QSRs and the quality requirements can significantly contribute to achieving compliance fast, resulting in saving significant amount of time and efforts and bringing innovative medical products to the market faster.

This webinar will discuss QSRs, requirements and compliance. This session will familiarize participants with the current Good Manufacturing Practice (cGMP) for medical devices including in vitro diagnostic devices. At the end of the webinar, you will get empowered in a way that you would plan, develop, maintain and implement the relevant procedures efficiently and effectively.

• QSRs for medical devices and in vitro diagnostic devices.
• Definitions.
• Flexibility of the QSRs.
• Quality system (QS) requirements.
• Management responsibility and personnel.
• Audits.
• 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:

This webinar will be valuable for anyone in global medical device industry including, but not limited to, those working on drugs, biologics and in vitro diagnostic devices who are involved in current good manufacturing practices.

The following employees who will benefit include:

• Manufacturing professionals.
• Regulatory affairs (associates, specialists, managers, and directors).
• Clinical affairs (associates, specialists, coordinators, managers, directors and VPs).
• Quality assurance, quality control, and quality systems (associates, specialists, engineers, managers, directors and VPs).
• Research and development (associates, scientists, managers, directors and VPs).
• Product and development (associates, scientists, managers, directors and VPs).
• Site managers, and consultants.
• Contract manufacturing organization (associates, scientists, managers, directors and VPs).
• Contract research organization (associates, scientists, managers, directors and VPs).
• Senior and executive management (VPs, SVPs, Presidents and CEOs).
• Contractors and subcontractors.

Instructor Profile:

Dr. David 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. In 2009, Dr. Lim served as a panel member during the FDA’s Transparency Public Meeting. Prior to founding his own consulting firm (www.RegulatoryDoctor.com/davidlim), Dr. Lim was Senior Vice President of Scientific and Regulatory Affairs at Aquavit Pharmaceuticals, Inc. in New York, wherein Dr. Lim provided inspiring and actionable solutions for sustainable business operation. Dr. Lim as Regulatory Doctor provides practical, actionable and strategic solutions integrated with emotional intelligence (EQ) skills for all aspects of global regulatory, quality, clinical and compliance matters. Over the years, Dr. Lim has analyzed over 1,000 FDA warning letters. Dr. Lim has also attended more than 50 FDA Advisory Panel Meetings and analyzed the subject matters and decision-making processes in detail. Dr. Lim is familiar with more than 200 medical products (medical devices including IVD products, biologics, drugs and combination products). Dr. Lim is a certified professional for regulatory affairs (RAC) and also is a certified quality auditor (CQA) by the American Society for Quality (ASQ). Dr. Lim is an auditor, regulatory coach, consultant and instructor for global matters pertaining to regulatory affairs, regulatory compliance, quality and clinical affairs. Currently, Dr. Lim is serving as a faculty at the Regulatory Affairs Professional Society (RAPS) and is an advisor to the Presidents and CEOs of FDA-regulated industry.

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