October 25, 2017 2:00 pm to 5:00 pm
Assembly Room C - 1W24, Somerville
This training is offered twice. The same material is covered at each session.
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
- Introduction to 21 CFR Part 11 and Data Integrity Controls
- Review of 21 CFR Part 11 and relevant data integrity requirements for GCP
- Computer system validation overview for eClinical systems
- Examples of GCP data integrity findings and issues, including regulatory observations