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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.
October 02, 2020
The case for migrating from a paper-based quality management system to a digital platform is presented.
A comprehensive rewrite of Annex 1 has been proposed and aims to organize and structure requirements in 10 specific sections.
End-to-end traceability can provide more value than just securing drug product safety.
The agency published recommendations for the development of drugs and biologics for the adjuvant treatment of renal cell carcinoma.
Drug shortages and supply chain challenges bolster FDA efforts to promote modern manufacturing.
Regulatory bodies are adapting to new ways of working to cope with the impact of COVID-19.
The amount of detail included in SOPs may help a company stay compliant, says Susan J. Schniepp, Distinguished Fellow at Regulatory Compliance Associates, LLC.
The guidance discusses acceptable clinical endpoints for demonstrating effectiveness of drugs developed to treat opioid use disorder.
The European Medicines Agency has started a rolling review of AstraZeneca’s COVID-19 vaccine.
October 01, 2020
Symbiosis has successfully completed a scheduled inspection by MHRA.