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 ...
Laser micromachining is a versatile process that can be used for an array of medtech applications. Yet when using it, it is crucial to select the appropriate method of process qualification or ...
VP and CISO for Mandiant, helping guide the company's product and solutions strategy and host of the Cyber Security Effectiveness Podcast. Understanding the effectiveness of your company's security ...
A moldmaker said recently that it sometimes takes him up to eight months to validate a large, high-cavity medical mold. Maybe this surprises you, but it doesn’t surprise many OEMs in the medical and ...
The track by which API manufacturing processes are prepared for commercial use is comparable to overlapping integrative process evaluations at commercial scale. This ensures the process is ...
Pharmaceutical manufacturing requires defining quality target product profiles and critical quality attributes (CQAs) to ensure desired product quality. Process development identifies critical process ...
Dublin, Oct. 28, 2025 (GLOBE NEWSWIRE) -- The "Biopharmaceutical Manufacturing Process Validation (Nov 17th - Nov 18th, 2025)" training has been added to ResearchAndMarkets.com's offering. This ...
A recent change in outlook at the U.S. Food and Drug Administration (FDA) — the government body that regulates the use of devices and substances in medical care — has escalated the already rigorous ...
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