Regulatory Affairs Professionals Society

MedCon: FDA officials say risk management is biggest hurdle for inspections under QMSR

Key changes with the QMSR include a greater focus on risk management, a culture of quality, and lifecycle integration. One of ...
JD Supra

FDA updates compliance program inspection manual for the QMSR age

On February 2, 2026, the U.S. Food and Drug Administration (FDA) published its anticipated compliance program manual, Inspection of Medical Device Manufacturers (CP 7382.850), to explain how the ...
Fierce Pharma

FDA expectations create potential friction in new Form 483 response guidance

Looking to clarify its expectations on manufacturer responses following inspections, the FDA earlier this year unveiled, for ...
RAPS

Updated FDA Manual Offers Inside Look at Inspection Protocols

Updated FDA Manual Offers Inside Look at Inspection Protocols The US Food and Drug Administration (FDA) earlier this week published its 2017 version of a chapter of its investigations operations ...

2 Day FDA Inspections Readiness Webinar: What to Expect, How to Prepare & Avoid 483 Observations (LIVE EVENT & ON-DEMAND: May 13th - May 14th, 2026)

The primary market opportunities lie in equipping professionals with practical skills for preparing, managing, and responding to FDA inspections. This training addresses common challenges and ...
JD Supra

The QMSR Goes Live and FDA Implements a New Medical Device Inspection Technique

On February 2, 2026, the U.S. Food and Drug Administration’s long-awaited harmonization of the medical device good manufacturing practice regulations with the international ISO 13485 standard, Medical ...