FDA, EU Notified Bodies, and other regulatory authorities investigate the capability of organizations to identify processes that require corrective and preventive actions.
Organizations should provide evidence that they have the required means and abilities to analyze failures and nonconformities, then set up corrections, corrective actions and corrective actions on duly manner.
This webinar shall provide insight of how to establish CAPAs that shall provide the organization the confidence that the organization is mature enough to handle its own failures and avoid future nonconformities
This webinar shall introduce:
Quality Assurance & Regulatory Affairs Expert for products and companies primarily related to medical devices and telecom that meet the real needs of their clientele. Substantial experience gained in various multi-discipline technology industries (Medical Devices, Telecom & Military), and give a high-value contribution to quality and reliability projects related to the medical device and telecom industries.More than 25 years of experience in QA; including MD&D RA & QA (EU-MDD/MDR, 510k);QMS (21CFR - Part820, ISO13485, MDSAP, TL9000, ISO9001). EH&S Systems; QA/RA representative in R&D Projects; Risk Analysis as per ISO14791& ISO31000; EMC & Safety Certifications Supply Chain QA & Supplier QA; CAPA; Training; Six Sigma; Process Validation; 5S and Lean Production; Configuration Control.