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.

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.