Industry Training for Medical Device Manufacturers Professional DevelopmentAAMI offers all of its Quality System training programs on an in house basis learn more here. Registration forms 2. Registration and 2. Registration. Application of Agile to the Development of Medical Device Systems. For many years software development teams have been using Agile Software Development methods, but Agile is not just for software. Agiles Lean Product Development principles also apply to the development of hardware based products and systems. ISO 11135 provides guidelines on the validation, process control routine monitoring of an ethylene oxide sterilization process for medical devices. T 08061 2010 iso 1113712006 3. This two and a half day course goes beyond small team and software only applications and demonstrates how Agile practices can be used in the development of medical device systems. September 1. 92. Arlington, VAApplying Human Factors to Improve Instructional Materials as Part of the User Interface. This two day course provides participants with a process and methodology for those involved in the design, development and human factors testing of instructional materials for medical device users that is consistent with industry standards and guidelines including FDA, the AAMI 3 Day Human Factors Workshop and AAMI TIR 4. Faculty with a combined 5. September 1. 01. Arlington, VACorrective and Preventive Action CAPA Requirements and Industry Practice. This 2 day course provides intensive coverage of the elements of a corrective and preventive action CAPA system. Some primary topics include the purpose of a CAPA system and how it is integrated throughout a Quality Management System appropriate data sources and how to coordinate, analyze and manage them methods for verifying and or validating actions how to write good CAPA plans how risk management is used in conjunction with the CAPA system and 2. CRF and ISO 1. 34. Catalog/Data/110/11014/16.gif' alt='Iso 11137 Sterilization' title='Iso 11137 Sterilization' />June 1. Arlington, VADesign Control Requirements and Industry Practice. This intensive 2 day course covers the practical application of the design control requirements of the Quality System regulation to medical devices. This course offers FDA and industry the unique opportunity to participate in a shared learning experience. Examples of design control tools, templates, and practices, in use by AAMI member companies, stimulate discussion and provide a practical resource for future reference. Case studies and situation analyses are used throughout the program to help participants analyze potential areas of noncompliance, identify improvements, and evaluate the various methods of managing a design control program. The content focuses on the how tos of implementing a program that meets FDAs design control requirements while ensuring a fast and efficient flow of new products. November 1. 31. 5, Dublin, Ireland. December 4 6, San Diego, CAFebruary 1. Arlington, VAMay 2. Dublin, Ireland. August 2. Arlington, VASeptember 57, 2. Freising, Germany. Developing and Validating Software for the Medical Device Industry. This 3 day workshop provides attendees with guidance on designing software validation plans that build confidence in the software and comply with regulatory requirements. EN ISO 111372, Sterilization of health care products. Radiation. Establishing the sterilization dose, has just been updated. The new 2015 Edition is being. The workshop is exercise driven to allow attendees to apply appropriate validation tools and techniques for embedded device software, off the shelf software, and quality system non device software. Case studies on traceability analysis, requirements writing, test designs, and validation planning give examples and possible solutions to validation activities. Effective Application of Agile Practices in the Development of Medical Device Software. Upon completion of this 2 day course, participants will be able to evaluate the challenges with the use of Agile practices and be prepared to adapt these practices as needed to ensure the development of compliant, safe, and effective products. This course builds on the concepts in AAMI TIR4. Guidance on the use of agile practices in the development of medical device software. October 1. Las Vegas, NVHuman Factors for Medical Devices. This 3 day course offers participants a comprehensive overview to human factors as it relates to medical devices. Items Hack Wow. It includes regulatory requirements of FDA, specifically the interpretation from the Center for Devices and Radiological Health CDRH Human Factors Team, as they relate to human factors, and the process of applying human factors in design controls during the design of a medical device. The course also includes the regulatory perspective of the Center for Drug Evaluation and Research CDER and the impact of human factors on pharma. November 1. Arlington, VAJanuary 3. February 1, 2. 01. Arlington, VAApril 3. May 2. 01. 8, Arlington, VASeptember 1. September 1. 9, 2. Arlington, VAOctober 1. Dublin, Ireland. Industrial Ethylene Oxide Sterilization for Medical Devices. This highly interactive 3. The program combines classroom lecture with real life scenarios to illustrate concepts and situational analyses that provide participants with the opportunity to apply what they learn to actual sterilization scenarios. Some of the topics to be covered are validation and requalification validation reports, protocols, and documentation product adoption troubleshooting process changes and process equivalency product release methods and optimization of sterilization process. August 2. 83. 1, 2. Arlington, VAIndustrial Sterilization for Medical Devices. Industrial Sterilization for Medical Devices is a comprehensive 4 day course covering essential information on sterilization technologies and methods, sterilization standards, FDA requirements, critical factors in product design and product release decisions, and much more. Integrating Risk Management into the Quality System. This comprehensive 2. March 1. 21. 4, 2. Arlington, VAProcess Validation Requirements and Industry Practice. This 2. 5 day course provides attendees with practical tools and techniques for process validation requirements for FDAs 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 Post Course Test. This optional, one hour, self assessment tests your mastery of the course materials and your ability to correctly interpret the Quality System regulation. This optional post test which is available online for 2 weeks following the end of the program, will be available to all participants. April 1. 82. 0, 2. Arlington, VAMay 2. Dublin, Ireland. Purchasing Controls Supply Chain Management. This 2 day course provides extensive information on effective implementation of supplier selection and controls. This detailed course covers the key aspects of supplier controls, from planning for supplier assessmentselection, to defining acceptance activities, to monitoring supplier performance. Each topic is presented from a practical perspective, with links to the requirements of the Quality System regulation, the ISO 1. Global Harmonization Task Force guidance. The course also covers life cycle management approaches for a medical device manufacturing organizations supply chain. The course includes substantial hands on exercises to allow attendees to apply concepts and interact with colleagues, and provides specific industry examples. April 2. 52. 7, 2. Arlington, VAQuality System Requirements and Industry Practice.