This week, Principal Engineers Mark Tschetter and Tim Bottoms attended a course focusing on the FDA's Quality System and its application to medical devices. The program, provided by the American Association of Medical Instrumentation (AAMI), was held in Phoenix, Arizona. The 2.5 day course--titled "Design Control Requirements & Industry Practice"--provides regulatory affairs experts, quality systems professionals, manufacturing engineers, and process development engineers with the knowledge and skills needed to comply with the process validation requirements of the FDA's Quality System regulation while offering information on how to implement an effective validation program. The knowledge gained by Mark and Tim will greatly help Logikos to help our customers whose products and processes must meet the FDA's requirements. Only a handful of people in Northern Indiana have completed this program. Read more about this course at AAMI's website (www.aami.org).