Medical device equipment manufacturers work in an environment where product quality isn't just a competitive advantage, it's a regulatory necessity with direct implications for patient safety. As ...
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 ...
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 ...
Last year, FDA inspections in pharmaceutical and medical device companies cracked down on cleaning procedures and complaint handling. Here's what local companies should know. The Food and Drug ...
(Reuters) - Manufacturers' tests of procedures to clean medical scopes linked with "superbug" outbreaks contained flaws that render their cleaning instructions unreliable, according to a senior ...
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 ...
DUBLIN--(BUSINESS WIRE)--The "Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation): 2-Day Workshop "conference has been added to ResearchAndMarkets.com's ...
Arbour Group, a member of the Oracle PartnerNetwork, announced that it is teaming with Oracle to provide a comprehensive solution to support FDA software validation requirements, including Part 11, ...
March 2 (Reuters) - Manufacturers' tests of procedures to clean medical scopes linked with "superbug" outbreaks contained flaws that render their cleaning instructions unreliable, according to a ...
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