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It is important to understand the differences between risk-based decision making and other decision making in a pharmaceutical quality system.
Validating computerized systems is required to demonstrate adherence to data integrity, says Susan J. Schniepp, distinguished fellow at Nelson Laboratories, LLC.
Quality-by-design risk assessment workflows can be laborious and have limited capacity to connect with vast volumes of prior knowledge generated by organizations. ecosystem.
November 16, 2021
Richard Denk, Senior Consultant Aseptic Processing and Containment, SKAN AG, discusses the evolution of aseptic processing with a particular focus on isolators.
November 15, 2021
New equipment meets needs for faster vial labeling and RFID for unit-level serialization.
Patrick Nieuwenhuizen, Senior Manager/Consultant, PharmaLex, discusses changes to regulatory requirements, quality risk management, audits, and operational considerations of aseptic processing.
Global supply chain experts examine implications of the DSCSA as well as topical considerations around the EU's FMD in this serialization video series ft. manufacturing, packaging, software, and regulatory experts.
November 12, 2021
The White House has nominated Robert Califf to head FDA, ending months of uncertainty about the future path for the high-profile agency.
The Democratic legislative proposal to authorize price negotiations on costly medicines covered by Medicare has drawn opposition from brand pharmaceutical and biotech companies.
European Medicines Agency (EMA) granted Rafael’s CPI-613 (devismat) an orphan drug designation for the treatment of refractory or relapsed Burkin’s lymphoma.
November 11, 2021
The agency is recommending the authorization of Ronapreve (casirivimab/imdevimab) and Regkirona (regdanvimab), two monoclonal antibody drugs, for treating COVID-19.
November 10, 2021
The agency is evaluating Moderna’s application for use of Spikevax in children aged 6 to 11.