In this webinar would apply to computerized systems that create source documents (electronic records) that satisfy the requirements in 21 CFR 312.62(b) and 812.
Areas Covered in the Session:
What are source documents and why are they important? (FDA and ICH GCP E6 Guideline)
What are required characteristics for source documents?
What is 21 CFR Part 11?
How can you apply 21 CFR 11 and ICH E6 to source documents?
How EMR Data is used in Clinical investigations
How to plan electronic source document deficiencies
Who Will Benefit:Investigators
Clinical Research Coordinators
Device and Drug Study Clinical Research Associates
Clinical Research Associate Managers
Quality Assurance Personnel
Regulatory Affairs Personnel
Angela Bazigos Seasoned Executive with 40 years of experience in the Life Sciences & Healthcare Industries. Positions include Chief Compliance Officer http://morflearning.com/angelabazigos/. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Turnarounds and Business Development.
Event Fee: One Dial-in One Attendee Price: US$150.00
Compliance4All DBA NetZealous,