
Is FDA getting tired of writing warning letters? A new draft guidance shows how companies should respond to Form 483 observations.
Mahboubeh Lotfinia works as a qualified person and quality partner at F. Hoffmann-La Roche and is trained in GMP/GDP audit execution and CSV (computerized system validation).

Is FDA getting tired of writing warning letters? A new draft guidance shows how companies should respond to Form 483 observations.

Does AI/ML help to enhance chromatographic peak integration? What do regulators say? Are you being seduced by technology?

Protecting your network chromatography data system (CDS) data is critical and a service level agreement (SLA) with your IT provider is vital. What should be included? Are SLAs for in-house IT and SaaS (software as a service) similar?

October 23rd 2025

Published: April 7th 2025 | Updated: April 7th 2025