Quality System Training Programs
Designed to facilitate and enhance the dialogue among medical device professionals from both the manufacturing and regulatory environments, AAMI’s comprehensive and interactive 2- to 4-day training programs provide a unique learning experience for quality assurance/regulatory affairs professionals; design, human factors, process, and software engineers; risk management managers; process owners of CAPA or supplier/purchasing activities; document control specialist; compliance officers; and standards application managers.
Participate, share, and learn with industry and regulatory representatives from around the globe.
To download the 2013 training brochure in pdf, click here.
Course Offerings
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Quality
System 4 day comprehensive course with optional ½ day exam for experienced quality systems professionals. Content is based on the body of knowledge developed jointly by representatives of the medical device industry and the FDA. |
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Design Control 2½ day intensive course for experienced quality systems professionals, including new product and R&D team members. The content focuses on the how-to's of implementing a program that meets FDA's design control requirements while ensuring a fast and efficient flow of new products. |
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Risk
Management 2½ day course for medical device manufacturers presents risk management concepts used throughout the quality system as well as the lifecycle of the product, from design, to manufacturing, through post-production. The program is designed for those who need a better understanding of risk management practices and how they are incorporated into the quality system. Those looking for guidance on regulatory requirements and ways that standards are related to risk management will also benefit from this program. |
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Process
Validation 2½ day intensive workshop provides the knowledge and skills needed to comply with FDA's process validation requirements while offering information on how to implement an effective validation program. Recommended for regulatory experts, experienced quality systems professionals as well as manufacturing and process development engineers. |
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Safety Assurance Cases This 3 day interactive course is geared towards medical device manufacturers who are involved in creating or reviewing safety assurance cases, such as engineers, risk managers, and regulatory and quality professionals. Instruction will provide attendees with an understanding of safety assurance cases and how they can be used to demonstrate the validity of safety claims made for medical devices. |
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Software
Validation 3 day course focuses on the requirements contained in the Quality System regulation specific to software validation. Explores the latitude and flexibility of FDA's expectations and provides conceptual ways to meet compliance requirements. |
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Software Validation Workshop This 3 day workshop provides attendees with guidance on designing software validation plans that build confidence in the software and comply with regulatory requirements. Workshop is exercise-driven and includes case studies. |
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Corrective and Preventive Action Requirements and Industry Practice This 2 day course provides intensive coverage of the elements of a corrective and preventive action (CAPA) system. After completing the course, participants will understand the essentials of an effective CAPA system and understand what is required for compliance with the FDA's Quality System regulation. |
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Human Factors for Medical Devices 3 day course providing an introduction to human factors, regulatory requirements of FDA as they relate to human factors, and the role of human factors in design controls. Provides a basic foundation for application of human factors, with discussions on user models and task analysis; anatomy of use errors; and task analysis as a basis for planning human factors efforts. |
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Document Control and Records Management for Medical Devices 2½ day program providing skills and tools needed for quality improvement and business acuity within the organization. Upon completion of this course, participants will be able to use documentation as a tool to facilitate compliance with the Quality System regulation and the ANSI/AAMI/ISO 13485:2003 standard. |
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Industrial Sterilization
4 day course covering sterilization processing in a medical device manufacturing environment. Addresses sterilization technologies and methods, sterilization standards, FDA requirements, critical factors in product design and product release decisions, and much more. Recommended for those who are relatively new to the sterilization process environment and need information to help them better understand the principles and science of industrial sterilization. |
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Radiation
Sterilization for Medical Devices 3½ day course providing intensive coverage of principles, processes, best practices, and industry standards in radiation sterilization for medical devices. Some of the topics covered are: FDA expectations regarding successful submissions and inspections, recalls, problem solving, and risk avoidance; scientific theory and principles of radiation sterilization; the new 11137 series radiation sterilization standards. |
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Industrial Ethylene Oxide Sterilization for Medical Devices Workshop 3 day workshop providing intensive coverage of principles, processes, best practices, and industry standards in ethylene oxide sterilization for medical devices. 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. |
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Statistics Workshop - Fundamental Statistical Tools and Methods |
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Purchasing Controls & Supply Chain Management Course 2½ day course provides extensive information on effective implementation of supplier selection and controls. The course also covers life-cycle management approaches for a medical device manufacturing organization's supply chain. |
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