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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)...
127 views0 comments
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...
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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...
17 views0 comments
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.
29 views0 comments
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...
67 views0 comments
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...
32 views0 comments
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...
236 views0 comments
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...
721 views0 comments
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,...
1,342 views1 comment
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