|Session Title: ||What is the True Meaning of FDA’s April 2016 Guidance Document on Data Integrity?|
|Facilitator Name:||Christopher Hahn||Facilitator 2 Name:||Christopher Hahn|
|Date: ||Tuesday, March 7, 2017|
|Start Time: ||02:00 PM|
|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?