Corrective 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.
Design Control Requirements and Industry Practice
This intensive 2½ 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.
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. 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 course.
Document Control and Records Management for Medical Devices
This 2½ day program provides participants with the skills and tools needed for quality improvement and compliance within their organization as related to the handling of documents and records. Course content utilizes real life scenarios with a variety of situations and case studies for analysis toward practical resolutions. Discussions with participants from other medical device companies and instructors will allow attendees to benchmark their documentation processes and practices within their quality management systems (QMS). The focus of this course is on how documents and records are controlled, the objective evidence required for compliance, and the linkages between documents and records to the various processes and activities within a QMS. Upon completion of this course, participants will be able to use documents and records as tools to facilitate compliance with the FDA’s Quality System regulation and ANSI/AAMI/ISO 13485:2003 as well as make decisions using the appropriate documentation and objective evidence.
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 TIR45:2012, Guidance on the use of AGILE practices in the development of medical device software.
Fundamental Statistical Tools and Methods for Quality Systems
This intensive 3-day workshop provides product and process experts a solid understanding of how to use statistical tools and methods to support Design Control, Process Validation, and Corrective and Preventive Action (CAPA). The content is based on the requirements of the FDA's Quality System regulation and the recommendations of the process validation guidance document developed by the Global Harmonization Task Force (GHTF). Hands-on computer-based training will stress practical application over theory.
Human Factors for Medical Devices
This 3-day course offers participants a comprehensive overview to human factors as it relates to medical devices. 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.
Industrial Ethylene Oxide Sterilization for Medical Devices Workshop
This highly interactive 3½ day, advanced workshop assumes that participants are experienced in working with an established ethylene oxide sterilization process, but are now challenged with ensuring the continued effectiveness and assessing change for the product or process. 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.
Integrating Risk Management into the Quality System
This comprehensive 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.
Integrating IEC 60601 with ISO 14971 to Facilitate Test Lab Approval of Medical Devices
The workshop will provide practical guidance for manufacturers on how to integrate IEC 60601 requirements with ISO 14971 requirements to facilitate Test Lab approval of medical devices. The approach taken in this workshop aims to manage the risks arising during the life cycle of the medical device from early design to production.
Industrial Sterilization for Medical Devices
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.
Process Validation Requirements and Industry Practice
This 2½ 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.
Purchasing Controls & Supply Chain Management Course
This 2½ 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 assessment/selection, 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 13485 standard, risk management considerations, and pertinent Global Harmonization Task Force guidance.
Quality System Requirements and Industry Practice
This intensive 4-day program provides quality system professionals with the basic knowledge and skills needed to develop a quality system program that conforms with the FDA's Quality System Regulation. Course content is the culmination of almost two years of consensus development on the part of a respected group of more than thirty quality system experts from leading device manufacturing companies, the FDA, and consultants to the industry. In 1999, this program was selected as part of the mandatory training for European Conformity Assessment Bodies under the US/EU Mutual Recognition Agreement. In 2003, FDA made attendance at the Quality System course part of the training criteria for its Accredited Persons Program.
Radiation Sterilization for Medical Devices
This 3½ day program covers principles, processes, industry best practices, and industry standards in radiation sterilization for medical devices. The course examines:
- FDA expectations regarding successful submissions and inspections, recalls, problem solving, and risk avoidance
- Scientific theory and principles of radiation sterilization
- The new global ANSI/AAMI/ISO 11137 series on radiation sterilization standards
- Integration of industry standards with the Quality System regulation
- Sterility Assurance Levels (SALs)
- Auditing processes for contract laboratories and sterilizers
- Radiation sterilization processing, including safety precautions, characteristics, constraints, and impact of radiation operations
Regulatory Requirements for Software Validation in the Medical Device Industry
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.
Risk Management and Human Factors
Properly identifying and mitigating use-related hazards is an important step in designing medical products. In this workshop, participants will learn how to incorporate risk management activities into their human factors planning. Topics include:
- How ANSI/AAMI/IEC 62366 and ANSI/AAMI HE75 relate to risk management
- Managing Use-Risk across the product lifecycle
- Identifying use-related hazards and failure modes
- Identifying and assessing risk
- Identifying critical tasks for testing
- Evaluating failures, close calls
- Use-Risk in post-market complaint investigations
- Use-Risk in design changes
- Final conclusions
Safety Assurance Cases for Medical Devices
This 2-day course provides 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. It covers the elements of assurance cases, the structure and approach for using them to demonstrate medical device safety, how to create and review a safety assurance case with good arguments and evidence, and common logic fallacies seen in assurance cases.