|IND, NDA, ANDA, MSDS, cGMP, GLP, GCP, CAPA, VQ, FDA and IRB regulations. Premarket approval (PMA), PMA supplements, 510K, Investigational Device Exemption (IDE), Humanitarian Device Exemption (HDE). Regulations governing Clinical Trials, ICH Guidelines, Informed consent process, and ethical issues involved in clinical trials. Knowledge of CTD/eCTD structure, FDA Regulatory Submission guidance. Tools: LIQUENT InSight eCTD Viewer, LIQUENT InSight for eCTD Submission Management®, SharePoint, ISI Tool Box, Galaxy, GOPATS, Mandarin, Thomas Cortellis. Windows7/8, Microsoft Office (Word, Excel, PowerPoint, Outlook), Adobe Acrobat Pro.|
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