Blog | R. Chase Consulting

Ricki Chase

May 235 min read

FDA QMSR - READ BETWEEN THE LINES AND DON'T STOP THERE

This blog provides another perspective on the FDA's adoption of ISO 13485 as the new Quality Management System Regulation (QMSR)...

Ricki Chase

May 223 min read

CDRH's Dr. Shuren Discusses Support for Market Entry

Dr. Jeffrey Shuren, Director of the US FDA's Center for Devices and Radiological Health (CDRH), stepped to the podium on May 15, 2024, at...

Ricki Chase

May 164 min read

AI Takes Center Stage at FDLIs Annual Meeting

The Food and Drug Law Institute's annual meeting on May 15-16, 2024, had an element of artificial intelligence (AI) throughout many...

Ricki Chase

May 162 min read

FDA's Dr. Califf Calls on Amplifiers to Help Combat Misinformation

FDA's Commissioner calls on everyone to fight misinformation and allocate time for the betterment of the country and its citizens.

Ricki Chase

Dec 7, 20234 min read

HIGHLIGHTS! ENFORCEMENT, LITIGATION AND COMPLIANCE

The Food and Drug Law Institute (FDLI) is on day two of the Enforcement, Litigation and Compliance conference. The annual meeting always...

Ricki Chase

Jul 27, 20233 min read

YES, You Are a Target

Once upon a time, long before FDA use the MAPP (Manual of Policies and Procedures) to tell us where they are going, a young investigator...

Ricki Chase

Jul 25, 20234 min read

WHY THE QUALITY SYSTEM INSPECTION TECHNIQUE (QSIT) SHOULD GO AWAY

If you work in the medical device arena and have products in the US, then you are likely familiar with the FDA’s Quality System...

Ricki Chase

Jun 20, 20236 min read

IN THE MIND OF AN EX-FDA INVESTIGATOR - INTERNAL AUDITS

Both during and after my career at FDA, individuals have asked me, “As an FDA investigator what are you looking for when…?”. I thought...

Ricki Chase

Jun 12, 202310 min read

FDA EXPERIENCE WANTED

If you work in pharma, biotech, medical devices, or any other industry regulated by the FDA, I feel safe in saying you probably have had,...

1,340 views1 comment