The Food and Drug Administration (FDA) recently issued a final guidance document, Validation and Verification of Analytical Testing Methods Used for Tobacco Products. This nonbinding guidance provides ...
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and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...
Dublin, June 25, 2025 (GLOBE NEWSWIRE) -- The "Computerized Systems Validation, Data Integrity & Cloud Computing In Pharma & Biotech" has been added to ResearchAndMarkets.com's offering. The seminar ...
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 ...
Expertise from Forbes Councils members, operated under license. Opinions expressed are those of the author. The life sciences industry is on the precipice of a new frontier—a future that is ...
Noven Pharmaceuticals, maker of the Fentanyl Transdermal System--an opioid patch used for long-term pain treatment--has come under fire by the FDA for poor process validation and for running equipment ...
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 ...
Is your medical device company ready for the QMSR shift? Engineer Aldo Vidinha explains why "checkbox compliance" is over and how the FDA’s alignment with ISO 13485 redefines quality as a connected, ...
DUBLIN--(BUSINESS WIRE)--The "Understanding FDA Design Verification and Validation Requirements for Medical Devices" webinar has been added to ResearchAndMarkets.com's offering. This webinar will help ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results