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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.
March 25, 2022
Pharma’s interest in decentralized clinical trials (DCTs) increases as it helps to expand their geographical reach and racial diversity
March 24, 2022
Congress is considering revising and improving policies related to drug development and regulation for possible inclusion in broader legislation to reauthorize FDA user fees.
March 21, 2022
Olympia Pharmacy is voluntarily recalling eleven lots of seven compounded products due to out-of-specification results.
Moderna, Pfizer, and BioNTech are seeking FDA approval for a fourth dose of their respective COVID-19 vaccines.
March 17, 2022
Viatris’ new drug-device is the first FDA-approved generic version of AstraZeneca’s Symbicort.
March 16, 2022
Any improper validation of methods is likely to result in regulatory agency deficiencies that range in degree of severity.
USP is advancing understanding and developing guidance and standards to assist industry in implementing continuous manufacturing.
March 15, 2022
Testing cleanroom garments while in use and during daily cleanroom operations is vital for contamination control.
Why critical thinking must be applied before technology to ensure regulatory compliance.
The importance of getting buy-in from regulatory authorities early in the development process is critical in order to establish meaningful specifications.