SGS Launches LinkedIn Life Sciences Community
The page will provide the life sciences community with a place to share ideas and find out about the latest laboratory bio/analytical and clinical research news and trends.
Preparing for Unannounced Audits
The long awaited unannounced audits for manufacturers of CE marked medical devices were started last year by almost all Notified Bodies. So how can manufacturers prepare for the changes?
Warning Letters Show Common QSR Problems
A quick review of the violations in 2014 Warning Letters shows that FDA inspectors are scrutinizing multiple areas of operation, from production to receipt of supplies to management responsibilities to CAPA systems.
Not having adequate resources, resulting in no audits being performed, is never going to be a viable excuse in the eyes of an FDA investigator. Quality Audits are mandated by the QSR and compliance with Section 820.22 is not optional.
If internal audits are performed with significant rigor and are truly being employed to identify and correct organizational issues, such audits become your best friend.
Are you Ready for a Notified Body Unannounced Audit?
There has been a lot of discussion about unannounced audits, and how companies need to prepare for these. But how can you prepare for something that you don’t know about? In this discussion, four industry experts offer some suggestions.
Medical Device Supplier Certification: the Rx-360 Approach
Rx-360, an international pharmaceutical supply chain consortium, which helps its members share best practices to ensure the integrity of the healthcare supply chain, is now gearing for growth in the device space. What lessons can device makers learn?
