Webinar - Events

As a “GxP” system, following Good Manufacturing, Laboratory and Clinical Practices, the computer system must be validated in accordance with FDA requirements. If electronic records and/or electronic signatures (ER/ES) are incorporated into the system, FDA’s CFR Part 11 guidance on ER/ES must be followed to assure data integrity is maintained. This webinar will focus on the efforts by FDA to modernize their own technology infrastructure, and what this means to industry. We will cover the Technology Modernization Action Plan (TMAP) that has been launched by FDA for this purpose and discuss specific actions that are planned and in progress. Areas Covered in the Webinar Learn how to identify “GxP” Systems Learn about FDA’s current program for modernization of technology, and how this will imp…

This webinar will help you understand the requirements of the new medical device regulation EU MDR 745/2017 and teach you how to create new required reports for the Notified Body and the Competent Authorities and how this process is connected to other processes in the quality management system according EN ISO 13485:2021. Why Should You Attend: You should attend this webinar to understand, what are the changes to the previous medical device regulation and how to implement the changes in your current quality management system according ISO 13485:2021 like post-market-surveillance plan and report and how to create the annual PSUR – Performance Safety Update Report to the Notified Bodies and EUDAMED in a simple and quick way. Your implementation need smart ideas to reach the right level to pa…