FDA releases analysis on drug product quality in 2022
There continues to be a correlation between low site inspection scores and potential drug recalls, states the US OPQ's 2022 annual report.
Source: europeanpharmaceuticalreview.com
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FDA Publishes Framework for Pharmaceutical QMM
The White Paper supports CDER’s long-held vision for pharmaceutical quality in the 21st century, described as a “maximally efficient, agile, flexible manufacturing sector” that is able to reliably produce high-quality drug products without extensive regulatory oversight.
Source: natlawreview.com
FDA White Paper Signals Shift To Performance-Based Reviews Of Mature Quality Systems - Healthcare
The US Food and Drug Administration (FDA) Office of Pharmaceutical Quality (OPQ) of the Center for Drug Evaluation and Research (CDER) recently published a White Paper laying out a framework...
Source: mondaq.com
FDA White Paper Signals Shift to Performance-Based Reviews of Mature Quality Systems | Sheppard Mullin Richter & Hampton LLP
The US Food and Drug Administration (FDA) Office of Pharmaceutical Quality (OPQ) of the Center for Drug Evaluation and Research (CDER) recently published a White Paper laying out a...
Source: jdsupra.com
Don't Let the Past Obstruct Your Zero-Trust Future
Don't Let the Past Obstruct Your Zero Trust Future The surest way to slow Zero Trust adoption is making it dependent upon security that already isn't working. At the same time, we shouldn't ignore our strengths. I'm in awe of those who create the future free from the constraints of the present. Take Wells Coates, for example. In his day, high tech was music and news played from furniture, polished brass and wood that housed heavy electronics. I have a Brunswick phonograph from this time period that's larger than my desk. Coates reimagined what radio could be when he designed the Ekco AD-65. S...
Source: darkreading.com