The FDA Process Validation training highlights opportunities in enhancing comprehension of constant process verification aligned with lifecycle concepts. It addresses early R&D phases through ...

The life science industry faces opportunities in enhancing cGMP compliance by developing robust, risk-based Validation and Verification strategies. Training on creating effective Master Validation ...

Course Topics Include: – FDA, ICH and USP Validation Requirements – Applying Validation Studies Consistent with Method Purpose – GMP Compliance during Validation – Validation Acceptance Criteria – ...

On September 13, 2022 the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...

In the highly regulated world of life sciences, quality isn’t a box to check—it’s a business imperative. For global en ...

BOSTON--(BUSINESS WIRE)--Sware, provider of the most complete software validation solution for innovative life sciences companies, today announced that it raised $6 million in Series B funding, ...

The FDA is preparing 2026 guidance on artificial intelligence in drug manufacturing and digital health technologies in clinical trials to align innovation with strict compliance requirements. Industry ...

The Food and Drug Administration is a government agency that regulates certain food, drugs, cosmetics, and medical products.

The US Food and Drug Administration (FDA) on Wednesday issued two draft International Council for Harmonisation (ICH) guidelines covering safety data collection and bioanalytical method validation for ...