IQ, OQ, PQ in the Verification and Validation Process Training Course: Master V&V Planning Aligned With FDA cGMP, ICH Q-Series, ISO 13485, and ISO 14971 Risk Management (ONLINE ...

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, ...
BioWorld

AMP says FDA asks too much of test validation in Section 564 draft

The U.S. FDA’s January 2025 draft guidance for test validation in public health emergencies drew only six responses, but pointed responses they were, indeed. As an example, the Association for ...
Morningstar

Tivic Health Enters GMP Manufacturing Validation Agreement with Scorpius BioManufacturing in Preparation for FDA Submission

Tivic Health® Systems, Inc. (Nasdaq: TIVC), a diversified therapeutics company, announced today it has entered a definitive agreement with Scorpius BioManufacturing to complete the GMP manufacturing ...
GEN

AI Human Genetics Platform Mystra Debuts for Drug Discovery, Validation

Officially unveiled at the American Society of Human Genetics (ASHG) 2025 meeting held in Boston, Genomics has launched Mystra, an AI-enabled human genetics platform designed to accelerate drug target ...