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Press Release Database
Recent press releases, indexed by topic.
SaaS · Healthcare
As life sciences, pharmaceutical, biotech, and medical device organizations accelerate digital transformation highlighted by the shift toward FDA Computer Software Assurance (CSA) draft guidance, GAMP® 5 (Second Edition) risk-based validation, and cloud/SaaS deployments ensuring 21 CFR Part 11 and EU Annex 11 regulatory compliance remains paramount. This practical training course equips QA/QC professionals, IT system owners, and regulatory auditors with actionable methodologies for modernizing the System Development Life Cycle (SDLC), conducting critical-thinking risk assessments, writing IQ/OQ/PQ test protocols, maintaining data integrity, and establishing audit-ready documentation across the full system lifecycle.
As life sciences, pharmaceutical, biotech, and medical device organizations accelerate digital transformation highlighted by the shift toward FDA Computer Software Assurance (CSA) draft guidance, GAMP® 5 (Second Edition) risk-based validation, and cloud/SaaS deployments ensuring 21 CFR Part 11 and EU Annex 11 regulatory compliance remains paramount. This practical training course equips QA/QC professionals, IT system owners, and regulatory auditors with actionable methodologies for modernizing the System Development Life Cycle (SDLC), conducting critical-thinking risk assessments, writing IQ/OQ/PQ test protocols, maintaining data integrity, and establishing audit-ready documentation across the full system lifecycle.
Aug 17 · 09:04·GlobeNewswire
AI · Healthcare
Opportunities include AI-enabled continuous inspection readiness, stronger GMP and data-integrity compliance, more effective CAPA and quality-culture systems, and training to help pharma and biotech firms meet evolving FDA expectations.
Opportunities include AI-enabled continuous inspection readiness, stronger GMP and data-integrity compliance, more effective CAPA and quality-culture systems, and training to help pharma and biotech firms meet evolving FDA expectations.
Aug 17 · 08:59·GlobeNewswire
Healthcare · Education
Designed to help pharmaceutical and biotechnology organizations navigate evolving global regulatory expectations from the FDA, EMA, and MHRA, this intensive 2-day virtual seminar delivers practical strategies for designing, implementing, maintaining, and continually improving a robust Pharmaceutical Quality System (PQS). The course covers essential PQS frameworks based on ICH Q10 and ICH Q9(R1) Quality Risk Management, focusing on key operational components including Corrective and Preventive Action (CAPA) systems, change control, supplier quality management, process performance and product quality monitoring, and audit readiness to prevent compliance gaps.
Designed to help pharmaceutical and biotechnology organizations navigate evolving global regulatory expectations from the FDA, EMA, and MHRA, this intensive 2-day virtual seminar delivers practical strategies for designing, implementing, maintaining, and continually improving a robust Pharmaceutical Quality System (PQS). The course covers essential PQS frameworks based on ICH Q10 and ICH Q9(R1) Quality Risk Management, focusing on key operational components including Corrective and Preventive Action (CAPA) systems, change control, supplier quality management, process performance and product quality monitoring, and audit readiness to prevent compliance gaps.
Aug 17 · 08:58·GlobeNewswire
Healthcare
In the news release, The Galien Foundation Announces 2026 Prix Galien USA Nominees for "Best Digital Health Solution," "Best Medical Technology," "Incubators, Accelerators and Equity," and "Best Startup", issued 13-Aug-2026 by The Galien Foundation over PR Newswire, we are advised by the...
Aug 17 · 08:13·PR Newswire
Healthcare
FORM 8.5 (EPT/RI)
Aug 17 · 08:11·GlobeNewswire
Healthcare · Biotech & pharma
Oslo, 17 August 2026: The Board of Directors of Zelluna ASA (the “Company”) hereby calls for an Extraordinary General Meeting to be held on 9 September 2026 at 13:00 CEST, regarding election of a new member of the Company’s Board of Directors (the “Board”).
Aug 17 · 05:45·GlobeNewswire
Finance · Healthcare
VANCOUVER, British Columbia, Aug. 16, 2026 -- Endeavour Silver Corp. (“Endeavour” or the “Company”) (NYSE: EXK; TSX: EDR) reports that operations at its Terronera mine in Jalisco, Mexico have been temporarily suspended since August 12th as the result of an illegal blockade by members of the nearby Ejido community regarding their concerns over road maintenance, assistance with medical services and communications, control and access to water supply and increased financial assistance. To date, the blockade has remained peaceful, orderly and respectful.
Aug 17 · 01:00·GlobeNewswire
Finance · Healthcare
NEW YORK, Aug. 16, 2026 -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that it has completed patient treatment in the MSB-DR004 pivotal randomized controlled Phase 3 trial of rexlemestrocel-L for chronic low back pain (CLBP) associated with the inflammatory condition of degenerative disc disease. The major milestone was achieved with 350 patients randomized and treated with either an intra-discal injection of rexlemestrocel-L or sham injection. Total patient numbers treated increased from 300 to 350 after strong demand from trial investigators to have their patients enrolled in the innovative program.
Aug 17 · 00:35·GlobeNewswire
Healthcare · Biotech & pharma
ROCKVILLE, Md. and SHANGHAI, Aug. 16, 2026 -- AbelZeta Pharma, Inc. ("AbelZeta" or the "Company"), a global clinical-stage biopharmaceutical company focused on the discovery and development of innovative and proprietary cell-based therapeutic products, today announced that...
Aug 17 · 00:00·PR Newswire
Healthcare · Cybersecurity
National class action firm offering free, confidential case evaluations to individuals affected by the Baylor Genetics cybersecurity incident HOUSTON, Aug. 16, 2026 -- Edelson Lechtzin LLP, a national class action law firm, is investigating data privacy claims arising from...
Aug 16 · 21:40·PR Newswire
Healthcare · Cybersecurity
National class action firm offering free, confidential case evaluations to Texas patients affected by the Lone Star Community Health Center / Aesto Health data breach CONROE, Texas, Aug. 16, 2026 -- Edelson Lechtzin LLP, a national class action law firm, is investigating data...
Aug 16 · 19:45·PR Newswire
Healthcare
The article explains how modern cosmetic dentistry uses subtle changes, advanced materials, and personalized planning to create results that complement a patient's natural smile. WARNER ROBINS, Ga., Aug. 16, 2026 -- What makes today's cosmetic dentistry look more natural than...
Aug 16 · 14:19·PR Newswire