On this episode, I do an active reading to begin to unpack the Quality Management System Regulations (QMSR) Final Rule that was issued by FDA in early February 2024.
Timestamps
- 0:00 Introduction
- 05:09 Initial Reactions to the idea of the QMSR
- 06:57 History of the Device cGMPs, QSR, and QMSR
- 11:52 What’s changing in 21 CFR 820?
- 24:59 What’s changing in 21 CFR 4 and Combination Products
- 33:20 Comments Review and Final Thoughts
Links
- QMSR Final Rule Amendments
- QMSR Final Rule FAQ
- 21 CFR 820
- 21 CFR 4 Changes Introduced
- Device cGMPs 21 CFR 820 (1978)
- Reserved Definition
- ANSI View-Only Copy of ISO 13485
Subhi Saadeh is a Quality Professional and host of the Combinate Podcast. With a background in Quality, Manufacturing Operations and R&D, he has worked in large Medical Device and Pharma organizations to support the development and launch of hardware devices, disposable devices, and combination products for vaccines, generics, and biologics.
Subhi currently serves as the International Committee Chair for the Combination Products Coalition (CPC), is a member of ASTM Committee E55, and has served on AAMI’s Combination Products Committee.
