Quality

Preparing for ICH E6(R3): Understanding QbD, CtQ Factors, & Risk Management

Explore the basics of quality by design, critical to quality factors, and what risks management means in the context of ICH E6(R3).

March 23, 2026
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Preparing for ICH E6(R3): Understanding the 11 Core GCP Principles

Explore the 11 GCP principles outlined in ICH E6(R3).

February 23, 2026
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Operationalizing ICH E6(R3) and QbD with a Quality Assurance Consultant

How can a QA consultant help your team fully adopt QbD?

December 18, 2025
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Evaluating Quality Culture in Clinical Research

We spoke with PharPoint’s Director of Quality Assurance to explore what a “quality culture” in the clinical research space entails in practice, beyond just the buzzword.

December 12, 2025
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Why Deming’s Out of the Crisis Still Shapes My Approach to Clinical Quality

QA Director Melisa Williamson talks about “Out of the Crisis” by W. Edwards Deming and how it has influenced her approach to quality.

November 21, 2025
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Meet Melisa Williamson, Director of Quality Assurance

Get to know PharPoint’s new Director of Quality Assurance, Melisa Williamson, with a quick Q&A.

September 29, 2025
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