CONFEREE NETWORKING

Basic Information

Session Title: What is the True Meaning of FDA’s April 2016 Guidance Document on Data Integrity?

Facilitator Name:Christopher HahnFacilitator 2 Name:Christopher Hahn
Affiliation:CSols, Inc.Affiliation:

Date: Tuesday, March 7, 2017
Start Time: 02:00 PM
Location: W186c

Overview

Following 21 CFR part 11 is an FDA expectation for companies using computerized systems with the potential to impact patient safety, product quality, or data integrity.
This will be a brainstorming session to discuss:
- The new Guidance document and what it means for you
- Data Integrity
- Identifying activities that need to be performed
--How does a risk assessment reduce the effort and remain compliant?
- Do vendor audits to reduce the effort?