These webinars will provide a working knowledge of Test Method Validation (TMV), also known as Measurement System Analysis (MSA) and Gauge R&R (GR&R). Concepts covered are also applicable to Analytical Procedures. The names are not important, the application of this very valuable statistical methodology is essential for a quality system. For more information: http://www.aami.org/events/eventdetail.aspx?ItemNumber=5749
This 3-day course focuses on the requirements contained in the Quality System regulation specific to software validation. The course explores the latitude and flexibility of the FDA's expectations and provides conceptual ways to meet compliance requirements. Relevant standards, FDA guidance documents, and other resources will be discussed that assist in determining compliance practices. For more [...]
As a medical technology developer who seeks to apply human factors engineering (HFE) effectively to produce safe and effective devices and to satisfy regulators' requirements and expectations, you may be frustrated that pre-existing guidance only describes how to perform specific HFE techniques but does not provide sample work products (e.g., test plans, test reports). A [...]
This comprehensive 2.5 day course for medical device manufacturers presents risk management concepts used throughout the quality system as well as the life cycle of the product, from design…to manufacturing…through post-production. For more information: http://www.aami.org/events/eventdetail.aspx?ItemNumber=5626