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 FDA’s Quality System Regulation, the FDA’s cGMP for Finished Pharmaceuticals, and ISO Standard 13485 for Medical Devices. The content reinforces the topics covered in the Process Validation Guidance document endorsed by the Global Harmonization Task Force (GHTF). Emphasis will be placed on best practices for quality systems in industry.

For more information:  https://us-tdm-tso-15eb63ff4c6-1626e-169df4b0a12.force.com/s/lt-event?id=a1Y2E000009UKJB

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, we will explore the general recommendations from TIR45 and apply them to the practical, real-world constraints of a medical device development organization. Attendees will learn how to read TIR45 so it can be used as a reference after the course, as well as learn concepts that will help break down the barriers their organizations face in the application of Agile methods. Attendees will leave with a better understanding of how Agile methods can and should be used in the development of medical device software and systems.

For more information:  https://us-tdm-tso-15eb63ff4c6-1626e-169df4b0a12.force.com/s/lt-event?id=a1Y2E000009UAu9

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 and even patient safety can be adversely affected in a severe way.

For more information:  https://us-tdm-tso-15eb63ff4c6-1626e-169df4b0a12.force.com/s/lt-event?id=a1Y2E000009UEQz