Computerized Systems Used in Clinical Investigations: the New FDA Guidance Training Course :

<strong>Course Schedule - Pre-recorded Course</strong><br/><br/>This program will provide key insights and features of the new FDA Guidance. Attendees will learn what the FDA expects when you use computer systems for clinical studies.how 21CFR Part 11, (ERES) applies and how this can help to support the EudraVigilance requirements for the European Medicines Agency.<br><br> This is an important and <b>very timely</b> program that can help to better plan the more efficient and compliant use of computer systems to support clinical studies.<br><br> <b>Module 1:</b> <li>Study Protocols</li> <li>SOPs</li> <li>Security</li><br><br> <b>Module 2:</b> <li>Audit Trails</li> <li>Data Management</li> <li>Change Control</li><br><br> <b>Module 3:</b> <li>Personnel</li> <li>EMEA Standards</li> <li>EudraVigilance Reporting</li>