Let's Combinate: Pharma + Medical Devices

Combination product quality and compliance for drug and device teams: 21 CFR Part 4, QMSR and ISO 13485, design controls, supplier and CDMO oversight, auditing, and inspection readiness.

I'm Subhi Saadeh, Founder and Principal of Let's Combinate. I'm a consultant, auditor, and trainer in combination product quality, an ISO 13485 Lead Auditor, ASQ CQA, and ASQ CQE, with experience across Pfizer, Gilead, and Baxter.

New videos every Monday: practical explanations of the regulations and standards that drug and device teams share, including the ICH quality guidelines (Q1 to Q14), and conversations with practitioners who build and inspect these products.

Consulting, audits, and training: https://www.letscombinate.com
Discuss a project: https://calendly.com/letscombinate/quick-chat
Contact: subhi@letscombinate.com