Quality Systems

Jul 02, 2018
Pharmaceutical Technology
Pharmaceutical Technology spoke with Sharon Ayd, executive vice-president of Pre-approval Pharmaceuticals and chief scientific officer at Regulatory Compliance Associates, about developing a corrective action and preventive action (CAPA) plan.
Jul 02, 2018
Pharmaceutical Technology
Knowing and addressing regulatory expectations early on can avoid unexpected delays later, says Siegfried Schmitt, principal consultant at PAREXEL.
Jul 02, 2018
Pharmaceutical Technology
FDA seeks more efficient testing to spur development of less costly biotech therapies.
Jul 02, 2018
By Pharmaceutical Technology Editors
Fagron Sterile Services is voluntarily recalling two lots of Neostigmine Methylsulfate 5mL syringes due to mislabeling.
Jul 02, 2018
By Pharmaceutical Technology Editors
The European Directorate for the Quality of Medicines & Healthcare highlighted the organization’s achievements in 2017, including the first mAb monograph.
Jul 02, 2018
Pharmaceutical Technology's In the Lab eNewsletter
By Pharmaceutical Technology Editors
The company unveiled its latest innovations to its mass spectrometry portfolio at ASMS in San Diego.
Jul 02, 2018
Pharmaceutical Technology's In the Lab eNewsletter
By Pharmaceutical Technology Editors
The company’s new LCMS-9030 system is designed for high resolution and accurate mass detection.
Jul 02, 2018
Pharmaceutical Technology's In the Lab eNewsletter
By Pharmaceutical Technology Editors
Thermo Fisher Scientific’s mass spectrometer combines mass-analyzer technology with an intelligent data acquisition strategy.
Jul 02, 2018
Legislators look to widen access to medications for addiction treatment and overdose emergencies.
Jul 02, 2018
The agency is asking firms to discuss internal quality metrics efforts as part of the approval process for new medical products.
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