CDER's Office of Compliance monitors the quality of marketed drugs through inspections, product testing, surveillance, and other compliance programs.The office of FDA CDER also develops standards for current good manufacturing practices (CGMP), clinical and good laboratory practices, and industry ...
MasterControl's corrective and preventive action (CAPA) software automates the management of the entire CAPA process. It connects quality events like nonconformances, deviations and customer complaints. The software improves product quality and safety to ensure adherence to GMP guidelines. ...
The key update to the NCCN Guidelines for treating esophageal cancer is the addition of immunotherapy to chemotherapy in the first-line setting for recurrent or metastatic squamous cell carcinoma, according toMichael K. Gibson, MD, PhD, Director of Translational Research for Esophago-Gastric Cancer ...
Articles in this issue USP Publishes Monoclonal Antibody Guidelines Maintaining the Stability of Biologics Springing Forward Reinventing the Cold Chain in a High-Stakes Market A Robust CAPA System for a Global Supply Chain CMOs Plan for Capacity Expansions ...
Things that FDA investigators look for in terms of CAPA What FDA investigators look for in terms of training control How medical device companies can apply a 'risk-based' approach to quality management What medical device firms ought to do prior to an FDA inspectionRole of FDA CDER Guidelines ...
Industry Brief:Simplify CAPA in 7 StepsIndustry Brief:Ensure Compliance by Digitising Change ControlIndustry Brief:What the Revised European Union’s Annex 11 Means to Life Science Companies GET FREE RESOURCES How MasterControl's Annex 11 Computerized Systems Comply with EU Annex 11 ...