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This 2.5-day course provides attendees with practical tools and techniques for process validation requirements for FDA's Quality System regulation and recognized Process Validation Guidance from the Global Harmonization Task Force. The program includes industry best practices and real-life process validation examples. Demonstrate Return on Investment (ROI) to employers by completing and passing the Process Validation [...]

The regulatory world for quality management systems (QMS) is changing fast. To succeed in today's global market, the manufacturers of medical devices must understand those requirements. This intensive 4 ½ day course provides quality system professionals with the information needed to develop and maintain a quality system program that conforms with the FDA's Quality System [...]

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

The International Conference on Medical Device Standards and Regulations will bring together regulators and standards leaders from around the world to report on some of the latest developments in this arena and discuss how medical manufacturers can prepare to ensure continued global market access and regulatory compliance. For more information:  http://www.aami.org/events/Content.aspx?ItemNumber=3071&navItemNumber=2929

On January 10, 2018, the FDA will hold a webinar for industry to review the “Technical Considerations for Additive Manufactured Medical Devices” guidance document and answer questions. We welcome your questions about this final guidance, so please mark your calendars to participate. No registration is required. For more details: https://www.fda.gov/medicaldevices/newsevents/workshopsconferences/ucm587582.htm

To all of our friends, clients, and associates being impacted by the wind, rain, storm surge, and flooding from Hurricane Irma, please know we are thinking of you and praying for your safety. Whether you are evacuating or hunkering down to wait it out, stay safe and stay strong, #FloridaStrong, #Irma2017. http://www.nhc.noaa.gov/

Focus’ CVS Mark Walker (also a member of AAMI’s faculty) will be an instructor at the Quality System Requirements & Industry Practice Course, Austin, TX, June 9-12, 2017.  The 4-day comprehensive course provides the basic knowledge and skills needed to develop a quality system program that conforms with FDA’s Quality System regulation.  For more info:  [...]