Medical Device Manufacturers Warned For CAPA Non-Compliance
Three recent warning letters from the Center for Device and Radiological Health [...]
13
06, 2017
6
06, 2017
Disciplined Patch Management is Essential: Take Note from the Energy Industry
The massive global cyber-attack on May 12 demonstrated a large lesson regarding [...]
30
05, 2017
FDA Enforcement Trends: Pharmaceutical Manufacturing Quality Focus
After a bit of a lull, the U.S. Food and Drug Administration (FDA) issued a batc [...]
16
05, 2017
How Will Real-World Evidence Impact 2017 FDA Guidances?
The Advanced Medical Technology Association (AdvaMed) wants the Food and Drug Ad [...]
8
05, 2017
CDRH Report: Quality Management Insights For Medical Device Manufacturers
FDA's Center for Devices and Radiological Health (CDRH) provided a glowing self- [...]
17
04, 2017
Prioritize QMS Process Automation or Risk Failure
A common pitfall in QMS process automation occurs with a poorly planned process [...]
11
04, 2017
Successful QMS Implementation Requires Clearly Defined Processes
Industry-leading quality management systems (QMS) are built with clearly defined [...]
10
04, 2017
China Addresses Life Sciences Regulatory Compliance Concerns
China has often faced criticism for lax regulation of drug and medical device ma [...]
3
04, 2017
FDA Warning Letters Emphasize Document Control System Compliance
First-quarter 2017 Food and Drug Administration (FDA) warning letters emphasize [...]
28
03, 2017
FDA States Clear cGMP Expectations for Combination Products
The Food and Drug Administration (FDA) recently released a final guidance on Cur [...]
