Designed to facilitate and enhance the dialog among medical device professionals from both the manufacturing and regulatory environments, AAMI’s comprehensive and interactive 2½ to 4 day training programs provide a unique learning experience for quality assurance/regulatory affairs professionals; design, process, and software engineers; risk management managers; compliance officers; and standards application managers.
Participate, share, and learn with industry and regulatory representatives from around the globe.
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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 course 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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Software
Validation 3-day intensive course geared towards those experienced in regulatory affairs, quality assurance and software product/process development. Supplies information and tools needed to comply with FDA's software validation requirements while offering information on how to implement an effective validation program |
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Corrective and Preventive Action Requirements and Industry Practice This 2.5 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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13485 Workshop 2½-day workshop focuses on the synergy between 13485 and the Quality System regulation, and ways that your company can apply best practices to comply with both. This 2½ day workshop provides intensive coverage on 13485, the Quality System regulation, and the complementary systems that specify the necessary requirements for conducting business in a regulated industry. Upon completion of the workshop, participants will be able to successfully implement and maintain a quality management system that complies with 13485 and the Quality System regulation. |
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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 3-day course 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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The Process and Logistics of Internal Auditing in a Regulatory Environment - One Time Workshop |