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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 01, 2017
As the date for implementation of the Drug Supply Chain Security Act approaches, bio/pharma companies and contractors should focus on key areas.
Supply chain risk monitoring is crucial for any company doing business today, and it doesn’t have to be expensive.
More life-sciences companies are starting to manage global suppliers holistically.
By working together and taking a QA-based approach, manufacturers and suppliers can reduce raw material testing requirements.
January 31, 2017
Trump met with pharma manufacturers and makes a statement focused on domestic manufacturing, FDA approvals, and drug pricing.
January 27, 2017
The agency recommended approval of a total of eight drugs at its January 2017 meeting, two of which are biosimilars.
January 25, 2017
The agency finds repeated CGMP violations at Porton Biopharma, Limited.
The company issues a voluntary nationwide recall due to the presence of particulate matter in a single vial.
FDA’s Office of Regional Affairs aims to implement Program Alignment initiative by May 15, 2017.
January 23, 2017
A study by EMA shows that drugs that received conditional marketing authorization gave patients earlier access to needed medications.