Key Updates: AAMI TIR48:2024 – QMS Recommendations for Combo Products (May 2024)

Upcoming Courses


AAMI TIR48:2024, “Quality Management Systems (QMS) Recommendations on Application of the U.S.FDA's CGMP Final Rule on Combination Products,” has been updated to reflect the evolution in regulations and guidance for applying the US FDA cGMP Final Rule on Combination Products. This training is intended to help drive understanding and insights into best practice and practical recommendations on application of Combination Products cGMP expectations. The training is intended to aid informed, risk-based decisions in establishing cGMP operating systems that support development, manufacturing, premarket regulatory evaluation, and ultimately commercialization of combination products. Included in the training is an overview of key terminology and examples, as well as a review of the cGMPs in accordance with 21 CFR Part 4A. Considerations for adopting a “Streamlined Approach” and Inspection Readiness will be reviewed. This training is also a valuable link to the broader, in-depth AAMI Combination Products Training program.


Over the course of three (3) hours, the attendee’s will be able to:

  • Understand the updated AAMI TIR48:2024, focusing on QMS recommendations for applying the U.S. FDA's cGMP Final Rule on Combination Products.
  • Analyze and apply best practices for meeting Combination Products cGMP expectations, enabling them to make informed, risk-based decisions in development, manufacturing, regulatory evaluation, and commercialization.
  • Familiar with key terminology, examples, and cGMPs in 21 CFR Part 4A. They will also grasp considerations for a "Streamlined Approach" and understand how to achieve Inspection Readiness.

Who Should Attend?

Those wishing to build familiarity and understanding of US FDA Combination Product cGMPs. Professionals who are responsible for establishing Quality Management Systems that need to conform to the Combination Product cGMPs. Device companies, Bio/pharmaceutical companies, CMOs and CDMOs who conduct activities in support of combination products manufacturing.

Virtual Training Information

Our virtual training environment allows you to have direct interaction with your instructors and your fellow attendees. AAMI uses Zoom for virtual classes. You can test your connectivity and ability to use Zoom at
For virtual training courses, we request that you register at least one week in advance of the course start date to allow sufficient time for shipping of training materials and devices (Please allow two weeks for non-U.S. addresses). If you register within these time frames, AAMI cannot guarantee you will receive material prior to the start of the course but you will have access to digital versions of the materials. If you have any questions, please email


susan neadle

Susan Neadle

Susan is Principal Consultant/ Owner of Combination Products Consulting Services, LLC. She has over 30 years of experience in the medical device/pharmaceutical/biotechnology industry. Susan partners with industry, applying her extensive Design-to-Value, Design & Process Excellence and Program Management skills, coupled with her combination products, medical devices, IVD and digital health expertise, to enhance the effectiveness, efficiency and consistency of medical product lifecycle management from development, submission and review through post market, in a dynamic global regulatory environment. She holds numerous patents and publications, and frequently speaks in public venues.