Classes & Workshops

How to Comply with 21 CFR 11 Requirements

When: Wed., May 2, 10-11:30 a.m. 2018

Overview: 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

Price: 150.00

Buy Tickets


Add a review


Select a star to rate.