COURSE DESCRIPTION

OVERVIEW

The use of electronic records continues to increase for Investigators, Sponsors/CRO and IRBs. How to apply regulations surrounding electronic signatures and documentation has long been a challenge to industry, and few best practices exist. Firms face important decisions on how to implement systems and establish related compliance programs that work cross functionally within an organization (and between organizations) that both mitigate risk while maintaining the efficiencies offered by electronic systems.

Adding to the confusion, there have been a series of guidance documents recently released by the FDA related to use of electronic systems, plus new guidance on the use of electronic systems and signatures. The question remains: How do I comply and maintain efficient, risk mitigated processes through electronic systems?

LEARNING OBJECTIVES

This interactive, online session will pull all recent guidance together to support operational decisions and help you form best practices across functional areas within an organization to ensure the flexibility needed to work across stakeholder systems and maintain audit readiness.

Attend this webinar, and you will:

• Identify specific quality systems elements to support the use of electronic systems regarding sponsor, site and IRB regulatory responsibilities
• Avoid the most common misconceptions related to use of electronic records and signatures
• Recognize the process of ensuring the use of electronic records supports the predicate rules for sponsors, investigators and IRBs
• Recognize best practices for oversight of the use of electronic records and signatures