21 CFR Part 11 Training

This training is offered twice. The same material is covered at each session.

REGISTER

Tuesday, October 24, 2017 from 8-11a.m. in the Bornstein Amphitheatre, BWH, Boston, MA
Wednesday, October 25, 2017 2-5p.m. in Assembly Room C - 1W24, Somerville, MA

Course Outline

1. Introduction to 21 CFR Part 11 and Data Integrity Controls
2. Review of 21 CFR Part 11 and relevant data integrity requirements for GCP
3. Computer system validation overview for eClinical systems
4. Examples of GCP data integrity findings and issues, including regulatory observations

This training is co-sponsored by Enterprise Research Infrastructure & Services and the Information Security & Privacy Office.