Tag: Inspections

Inspection Readiness: What is it and how do we get there?

This blog was submitted by Ashley Argiras, Associate Director, Quality Assurance, Vertex, and is a summary of a roundtable discussion held at the 7th Annual Avoca Quality Consortium Fall Member Meeting. Challenges in Implementing Successful Inspection Readiness Programs Senior leaders within organizations generally identify the need for inspection readiness (IR) programs. A critical challenge to […]

Is Your Organization Prepared for Risk-Based Inspections? Depends on Who You Ask.

With the adoption of ICH E6 (R2), risk-based quality management for clinical trials has become an expectation, and inspectors are starting to use these guidelines in their audits. However, The Avoca Group’s research, documented in the 2017 Avoca Industry Report, indicates that sponsors and providers both have work to do to be truly prepared for […]