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January 02, 2016
Siegfried Schmitt, principal consultant, PAREXEL, discusses how to streamline the document management process during market expansion.
December 07, 2015
While stakeholders generally welcome improvements to quality initiatives, they are concerned with how the new requirements will be implemented for more complicated supply-chain models.
September 02, 2015
Siegfried Schmitt, principal consultant, PAREXEL, discusses how to assure compliance for automated systems.
FDA’s proposed guidance for quality metrics raises questions about quantifying the tangibles and intangibles of quality culture.
QbD is improving the safety of solid-dosage drug products as well improving manufacturing processes, despite some industry reluctance.
September 01, 2015
To enable efficient monitoring systems, life-science companies need to effectively apply run rules.
August 02, 2015
Susan Schniepp, distinguished fellow, and Andrew Harrison, chief regulatory affairs officer and general council, both of Regulatory Compliance Associates, discuss the requirements for a successful corrective action and preventive action (CAPA) system.
Mitigating risk in the bio/pharmaceutical sector demands a holistic approach.
July 15, 2015
Checkweighers, metal detectors, x-ray inspectors, leak detectors, headspace analyzers, and optical inspection systems for packaging were demonstrated at INTERPHEX 2015.
July 09, 2015
Sepha's VisionScan Max can leak-test full production batches of blister packs.