FDAnews.com - Audioconference in May/June

MEDICAL DEVICE 21 CFR PART 820 (The Regulations)
1

Hi

I have been asked by FDAnews.com to give an audioconference in May/June on a CSV topic of my choice. After a little thought and consideration I have decided to give the conference on Audit Trails and their importance within a regulated environment.

At the moment I am researching material on this topic as the conference is scheduled for 90 minutes.

I will cover such topics as:

  • What is an Audit Trail
  • The importance of an Audit Trail
  • The Benefits
  • How to test an Audit Trail
  • Testing of the Audit Trail at the FAT stage
  • How long should an Audit Trail be maintained
  • When should the Audit Trail start
I would very much appreciate input from other members of this community so that I cover all the relevant sides of an Audit Trail.

Once I have delivered this audioconference I will make it fully available for all member’s which I will send as part of our monthly eletter.

Your opinions are very much appreciated.

If you would like to subscribe to this audioconference the link is

http://www.fdanews.com/conference/detail?eventId=495

Kind Regards