June 28, 2010 At Miracle Grand Convention Hotel
Most Frequent CARs in ISO 13485:2003, MDD and Relevant Medical device regulatory Audits was conducted by Mr. Parivat Akarapimarn, Deputy Manager of Medical & Health Services Department and ISO 13485, MDD, CMDR, JGMP and 9001 Lead Auditor.
This 1 day special training program is intended as introductory course to provide participants to have awareness and gain insight of major requirements of ISO 13485:2003, Medical Device Directive (MDD), and other Relevant Medical Device Regulatory Requirements e.g. JPAL ( Japanese Pharmaceutical Affairs Law), 21 CFR Part 820 (Quality System Regulation). Moreover, participants will be provided with tips for handling and managing quality management system / regulatory audits e.g. US FDA as well.