Market opportunities lie in enhancing risk-based V&V planning, focusing on DQ, IQ, OQ, and PQs to address cGMP deficiencies and regulatory expectations. By aligning with FDA, ICH, and ISO standards, ...
You know you need a validation master plan, but what should it include and what separates a strong validation master plan from an ineffective one? Marie Thibault We asked Ken Link, director of quality ...