Looking forward to connecting with colleagues at the PDA Universe!
Join Fran DeGrazio, Randy Kipnis, Justin Wu, and me to explore how expert consulting + QMSpace can support more connected execution of combination-products, from quality systems and risk management to reusable platform knowledge, lifecycle changes, and regulatory submissions.
On October 7, I’ll also be presenting “Real-Time Integration of Module 3 with QbD, Design Controls, and Risk Management,” exploring how live traceability keeps submission content connected to the underlying development evidence as products evolve.
Whether you’re scaling a combination-product portfolio, developing a delivery-device platform, or addressing quality-system gaps for combination products, stop by and share the challenges your team is working through.