From Validation to Assurance: How FDA’s CSA Guidance Is Transforming Pharmaceutical Quality
December 1, 2025
How risk-based assurance is transforming compliance, innovation, and digital quality systems across life sciences.
How risk-based assurance is transforming compliance, innovation, and digital quality systems across life sciences.
Understanding FDA Guidance on Delaying, Denying, Limiting, or Refusing a Drug or Device
Quality Assurance (QA) in Clinical Development has significantly changed over the past two
The following article is taken from June 15th Webinar – “Create a Quality Culture data
Since 2021, the Pharma Manufacturing World Summit has gathered SVPs and VPs of
In the evolving landscape of pharmaceutical regulation, the recent GDUFA III changes introduced
In session 4 of our Executive GxP Training program, Teresa Gorecki discusses understanding
The New 15% Rule Unfortunately, Warning Letters have become almost a feature of
In Teresa Gorecki’s second session of Executive-level GxP training, the two reviewed Regulatory
To navigate FDA warning letters amidst this complex landscape of regulations can often
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