In the past 18 months, the FDA has outlined clear guidelines for designing, documenting, updating, and monitoring AI-powered ...
It isn’t always clear when to choose to verify or validate manufacturing processes. But experts from the US Food and Drug ...
Finally, the terminology shift worth flagging is QMSR replacing the “Design History File” with “Design and Development File”, ...
Key market opportunities include gaining expertise in FDA compliance for computer system validation, implementing robust risk-based validation strategies, and addressing challenges in cloud, AI, and ...
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and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...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 market has opportunities in comprehensive training for computer system validation, particularly in regulated industries. Key areas include mastering FDA regulations, agile vs. waterfall ...
Course Topics Include: – FDA, ICH and USP Validation Requirements – Applying Validation Studies Consistent with Method Purpose – GMP Compliance during Validation – Validation Acceptance Criteria – ...
On January 11, 2026, the FDA issued two news releases putting forward reforms to the chemistry, manufacturing, and control requirements for cell and gene therapy products, one titled FDA Increases ...
Next generation sequencing (NGS) has revolutionized molecular diagnostic testing. It is important to note that, as with many molecular diagnostic tests currently in clinical use, there are very few ...
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, ...
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