A big challenge for Process Validation is to establish objective evidence that a process is capable of consistently delivering quality product. The goal of these two webinars is demonstrate how valid statistical techniques meet this challenge – and better yet, save time, money and resources. The application of valid statistical techniques is encouraged by the [...]
This two-part, four-session series begins with an introduction to AAMI TIR45, Guidance on the Use of AGILE Practices in the Development of Medical Device Software, and then addresses many of the key concepts and recommendations provided by TIR45. With a combination of slides (using Key Takeaways and Diagrams from TIR45) and dialogue with the audience, [...]
Today the news is inundated with stories about cybersecurity compromised businesses, public services, and government operations. Among those we often hear as being compromised are hospitals and healthcare-related organizations. When compromises to healthcare organizations do occur, they have frequently shut down a department’s or an entire organization’s operations so that their ability to deliver healthcare [...]
Regulatory Authorities place the responsibility of the Quality Management System firmly onto the shoulders of a medical device firm’s management team; however, many executives do not have an appreciation or awareness of these requirements. This course presents an overview of the QMS, with a focus on management’s roles and responsibilities to demonstrate an active commitment [...]