T Possibly Web-based Seminars

Reusable Device Cleaning Disinfection and Sterilization Validations Overview and Key Design Considerations for Device Engineers Validation of reusable medical devices requires that the manufacturer develop methods for cleaning (after use) washing to remove all foreign matter possibly disinfecting and repackaging for the next use. The diversity of medical devices their intended use and classification in accordance with the food and drug administration requires that the manufacturer develop and validate the reprocessing  more...

How to Prepare and Submit a Bullet Proof 510k and Latest FDA Proposed Changes to the Process - Webinar By GlobalCompliancePanel Overview: This 3 hour Webinar is a primer and overview to the premarket notification process, i. e., a 510(k). A 510(k) is a premarket submission made to FDA to demonstrate that your device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to PMA. There are three types of Premarket Notification 510(k)s that may  more...

Leadership in Manufacturing Contamination Control Webinar will be on March 18, 2010. Webinar will be presented by Teri C. Soli. The Microbiology Lab must take leadership in contamination control support for production because it is the hub of the necessary technical expertise. This broad manufacturing support role covers many areas, including routine raw material and product testing, disinfectant/ sanitant qualification, water and compressed  more...