Understanding Medical Device Laws and Regulations in Korea, Japan, China, and Hong Kong Hee Speaker: Dr. David Lim Webinar Code: GCT 300 153 Webinar Date: 15th September 2014 10:00 AM PDT | 01:00 PM EDT Webinar Duration: 60(Minutes) Webinar Description : This webinar is intended to help you get familiar with medical device laws and regulations in Asian countries: Korea, Japan, China, and Hong Kong. The medical devices are currently one of the fastest growing industries. The current knowledge and accurate understanding and adequate interpretation of global medical device laws, regulations and regulatory requirements have become increasingly important in our competitive global market. Areas Covered in the Session: Medical device laws and regulations Recent revisions on the laws and regulations: Korea, Japan, China and Hong Kong Definitions Device classification and rules Regulatory framework for medical devices in Korea, Japan, China and Hong Kong. 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 Instructors profile: Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Doctor (RegulatoryDoctor). Dr. Lim frequently presents global regulatory and quality compliance topics in various forums and meetings. Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past seven years. Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009. Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker. Dr. Lim leads and directs all research projects including, but not limited to, pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor. For more details please contact us at globalcompliancetrainings or you can reach us at 248-212-0588.
Posted on: Mon, 08 Sep 2014 19:45:05 +0000
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