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


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?