Global Harmonization Task Web-based Seminars

Medical Device Postmarketing Vigilance Reporting Update and Expectations for Manufacturers - Webinar By GlobalCompliancePanel Overview: Major postmarketing vigilance revisions are now in force. A revised medical device guidance document on postmarketing vigilance (MEDDEV 2. 12-1 rev 5) came into force on January 1, 2008. Providing more guidance than the previous version, the new document includes new reporting terminology and concepts such as "periodic summary reporting" and "trend reporting." Tuesday, June 12, 2012  more...

Designing and Implementing the Quality System for Combination Products - Webinar By GlobalCompliancePanel ...e International Conference on Harmonization (ICH) and the Global Harmonization Task Force (GHTF) guidances. The attendees will quickly learn and understand the quality systems principles through the many graphical visual techniques used in the seminar. A quality systems approach will be shown that simplifies and reduces the burden of compliance. You might even want to revamp your quality  more...

Full Day Virtual Seminar - Designing and Implementing the Quality System for Combination Products - by GlobalCompliancePanel The FDA generally defines combination products as a product composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device, and a biological product. Although there are differences between these quality systems, the quality principles embodied in the systems are the same. This course looks at these principles and the  more...

Medical Device Classification - Webinar by GlobalCompliancePanel In 1976, the FDA received authority to regulate medical devices. The plan, written into law, establishes three risk classes for devices (I, II, and III). The three risk levels require different types of control. The webinar explains the two dimensional sy The EUa ™s MDD classifies devices using a rule based system found in Annex IX of the MDD. Devices fall into four risk categories (I,  more...