Weak CAPA Programs Hit Globally by FDA Warnings
Life sciences companies around the world better make sure their Corrective and Preventive Action (CAPA) plans are in good shape before an inspector comes calling.
8
11, 2016
31
10, 2016
Is Your Change Control Program Ready for FDA 510(k) Scrutiny?
A trio of FDA 510(k) guidances demonstrate how important it is for medical device manufacturers to get a firm grip on document management and change control – especially when working within the Third Party (TP) Review Program or trying to determine if a medical device change warrants a new 510(k). The agency is attempting to make it easier on device makers if they understand how to work within the new system.
24
10, 2016
What You Need To Know About the FDA’s Mixed Device PMA Approval Report Card
If working with the FDA sometimes feels like reading tea leaves the Quarterly Update on Medical Device Performance Goals gives us more than our usual share of relatively hard data.
14
10, 2016
How Strong is Your QMS Program? New International Meddev Rules Challenge Complacent Organizations
It's time to get your compliance programs in order to meet some looming international regulatory compliance demands, experts including former Food and Drug Administration officials say. Having a firm grip on quality management (QMS) processes - especially document management and change control - will be critical to comply with such a disparate group of regulations working with so many regulatory bodies.
27
09, 2016
Cloud for quality and compliance management: A primer for life sciences companies
Here's what life sciences companies moving their quality and compliance management tools to the cloud can expect.
19
09, 2016
RAPS Preview: FDA CDRH Director Shuren Talks Priorities
FDA CDRH or Center for Devices and Radiological Health Director Jeff Shur [...]
5
11, 2015
FDA Eases Up a Bit on Enforcement Gas Pedal as Warning Letters Decline
Medical device warning letters and domestic inspections continue to show a slow [...]
3
11, 2015
Improving FDA Reviews of Combination Products
The FDA and Intercenter Consultations Just a few short weeks ago, Robert Califf, [...]
14
10, 2015
FDA Inspectors Leave Calling Cards For Medical Device Manufacturers Nationwide
Our latest round of warning letters emphasize the importance for medical device [...]
25
08, 2015
FDA Pilot Program Encourages Quarterly Malfunction Summary Filings
FDA will be taking applications starting Sept 1, 2015, looking for makers of cla [...]
