3-hr Virtual Seminar: Medical Device Regulations and Law in the US, EU and Canada

Why You Should Attend:

The global regulation of medical devices is rapidly evolving, integrating the regulatory systems of the most advanced medical device regulations. To be able to achieve sustainability and to remain competitive in global medical device markets, it is necessary to streamline the regulatory process what would help to reduce or eliminate differences between countries, gain regulatory compliance at a reduced cost, allow intended users and other stakeholders earlier access to advanced and innovative medical device products for treatments and improve healthcare in a safe and effective way during post-marketing through surveillance program.

This webinar is intended to walk you through how to streamline the regulatory process in a systematic manner in the US, EU and Canada. This 3-hr training will discuss medical device regulations and law in the US, Europe and Canada. It is designed to help the audience with their global compliance and regulatory intelligence. This seminar is a “How To Guide” intended to streamline the decision-making process in a systematic manner.

Areas Covered in the seminar:

• List and review of regulations and law in the US, EU and Canada.
• 21 CFR Part 820 and ISO 13485.
• Regulatory requirements for medical devices including in vitro diagnostic devices in the US, EU and Canada
• How to identify and meet the regulatory requirements?
• How to establish and maintain systematic methods to meet the regulatory requirements?
• How to establish and maintain systematic methods to improve quality?
• Instructor's unique regulatory strategy guide.

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. It is particularly useful for those who are engaged in the design and development of medical devices, combinations products (e.g., drug and devices, biologics and devices), and in vitro diagnostic devices including companion medical products. This webinar is a must for those who are directly or indirectly involved in handling regulatory submissions to the FDA, EU and Health Canada.

The following employees who will benefit include:

• 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)
• Marketing (associates, specialists, 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 in 1993. Since then, Dr. Lim has held various positions at Duke, US National Laboratories, Intrexon Corporation, Terumo and Center for Devices and Radiological Health (CDRH) at US Food and Drug Administration (FDA). Currently, Dr. Lim is Senior Vice President of Scientific and Regulatory Affairs at Aquavit Pharmaceuticals, Inc., in New York. Prior to Aquavit Pharmaceuticals, Dr. Lim served as Director of Regulatory Affairs at EraGen Biosciences, Inc., A Luminex Company in Madison, WI. 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, consultant and instructor for global matters pertaining to compliance, regulatory affairs, quality and clinical affairs.

Follow us :