Director, Quality and Regulatory Affairs,
Nancy, is the Director of Quality & Regulatory Affairs, Healthcare responsible for global coordination of Celestica's Healthcare Quality, Regulatory and FDA compliance. Nancy is Quality and Regulatory expert with fifteen years experience in regulatory affairs, quality systems, compliance, clinical quality, validation, auditing, quality control, data management systems, post market surveillance, supplier management and regulatory compliance in the areas of bio/pharmaceuticals, medical devices and combination products. Nancy has contributed to the success of both venture and public companies, establishing a track record of successfully achieving timely global regulatory approvals, initiating and effectively managing preclinical and clinical investigations and developing and maintaining effective and compliant quality systems in various healthcare sectors.
Most medical device manufacturers use FMEA as a part of their risk management system. Risk Management is required by ISO 13485 and risk analysis by the FDA's Quality System Regulations (QSR) and by of the EU medical device regulations. Recorded
How do you prevent becoming another FDA statistic? Poor corrective and preventive action (CA/PA) and investigations continue to be among top FDA Form 483 deficiencies issued to drug, biologic, and medical device manufacturers. Recorded