With short-form, impactful courses, AAMI Expert Insights bring you experienced perspectives on topics critical to your success
AAMI Expert Insights are short interactive virtual presentations from leading industry experts on topics critical topics in health technology, medical device development, and sterilization. New Expert Insights are being developed every month—check
back often to find the latest offerings!
Unpack the FDA’s paradigm shift in their approach to software validation by understanding the history of traditional software validation requirements and the intent of the new Computer Software Assurance (CSA) principles.
September 20-22 | 1:00-3:00 PM
AAMI is presenting a 2-part webinar on the Risk-Based Computer Software Assurance (CSA) approach for Production, Process, and Quality System Software (PPQS) that is detailed in the expected proposed FDA Draft Guidance. This part lecture and part interactive webinar will help you leverage critical thinking to greatly reduce the effort and cost of software validation.
Part 1: Understanding FDA’s current thinking on least burdensome approach to Computer Software Assurance (CSA)
Tuesday, September 20th | 1:00-3:00 pm Eastern
Discover the FDA’s paradigm shift in Software Validation approach by understanding the history of traditional Software Validation and the intent of the new CSA principles.
- Discuss background of Production, Process and Quality System Software Validation
- Define Computer Software Assurance (CSA)
- Identify the similarities and differences between CSA and traditional Software Validation
- Apply new paradigm CSA methods to validate PPQS Software
Part 2: Applying Computer Software Assurance (CSA) fundamentals to your Quality Management System (QMS)
Thursday, September 22nd | 1:00-3:00 pm Eastern
Learn how to modernize your QMS to leverage CSA Fundamentals and understand how to implement a risk-based approach to build confidence that your Production, Process and Quality System Software works as intended.
- Use critical thinking to eliminate non-value-added, burdensome validation activities from your QMS
- Incorporate new CSA fundamentals into your validation processes
- Participate in creating an outline for a Validation Plan/Report
-
September 12 to 15, 2022 Register
Understanding TIR45: Agile Methods for Medical Device Development
September 21, 23, 28, and 30 | 1:00-3:00 PM ET
This four-session series offers an introduction to AAMI TIR45, an overview of the latest guidance on the use of AGILE practices in the development of medical device software, and addresses many of the key concepts and recommendations provided by TIR45.
Join industry-leading instructor and co-author of AAMI TIR45, Kelly Weyrauch, to learn the concepts and recommendations provided by TIR45 and explore how to apply them to your context.
-
September 21 to 30, 2022 Register
Dive into QMSs with a focus on the roles and responsibilities of management in an organization quality system
September 12-15 | 1:00-3:00 PM
Regulatory Authorities place the responsibility of the Quality Management System firmly onto the shoulders of a medical device firm’s management team; however, many executives do not have an appreciation or awareness of these requirements. This course presents an overview of the QMS, with a focus on management’s roles and responsibilities to demonstrate an active commitment to their firm’s quality system.
The course will be structured into 5 segments:- SEGMENT 1: Management’s roles, responsibilities, and expectations as defined by regulatory authorities and ISO.
- SEGMENT 2: Describes management requirements for Design Controls and Risk Management and how to help ensure product safety, efficacy, and usability.
- SEGMENT 3: Overviews the non-manufacturing aspects of the QMS with an emphasis on resources and the advantages of a well-trained organization.
- SEGMENT 4: Covers manufacturing and the role of the QMS to establish and maintain control over the production process.
- SEGMENT 5: Highlights the importance of Monitoring and Feedback requirements, with an emphasis on CAPAs, Audits, Post Market Surveillance, and Management Reviews.
-
September 12 to 15, 2022 Register