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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.
February 03, 2022
Training is crucial for supporting GMP operations in commercial-scale bioprocessing.
For some manufacturers, the goal was to be fully compliant with the DSCSA, including both serialization and aggregation, from day one.
With data integrity regulatory violations on the rise, there is a need for better and more consistent validation management practices.
February 02, 2022
Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, details regulatory requirements for developing a quality manual.
As Europe moves closer to implementation of ISO IDMP standards, the bio/pharma industry is accelerating efforts to manage its data and documents more effectively.
The global nature of the COVID-19 pandemic emphasizes the critical importance of expanded vaccination.
The Digital Markets Act is transforming the use of digital content by the pharmaceutical industry.
Toxicology studies are an important and required aspect of drug development that are performed to ensure that drugs are deemed safe prior to patient administration and use in clinical trials.
February 01, 2022
CDMOs offer expertise and customization options for sponsors of orphan drugs.
January 31, 2022
The draft PREVENT Pandemic Act aims to secure supply chains, expand health data collection, and support access to vital medical products