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and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...

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 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 ...

Process validation is crucial for ensuring the quality of final products and the safety of these processes for manufacturing personnel and consumers in the pharmaceutical, medical device, and ...

Developing a medical device is a lengthy process. Prior to commercial distribution, FDA requires that the manufacturing process for the product be validated. Process validation is defined as the ...

The FDA is piloting real-time tracking of clinical trial data to speed detection of safety issues, starting with two proof-of-concept studies from AstraZeneca and Amgen. The initiative is part of a ...

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, ...