Live: One Dial-in One Attendee
Corporate Live: Any number of participants
Recorded: Access recorded version, only for one participant unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
Corporate Recorded: Access recorded version, Any number of participants unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
The presentation will include: where GDP can be found in the CFR, We will discuss definitions of documentation, raw data, record keeping, and some do's and don't's.
We will discuss what the CFR requires and how to interpret what the CFR states.
We will discuss how to write in forms and notebooks, what must be included in the SOP and where to find this information, whether in the CFR, USP, FDA or other sources.
Why should you Attend: Why attend? Those in quality must have a solid background in GDP. It is the lifeblood of Quality. FDA inspections can focus on the little things, like GDP, as poor GDP targets the focus of the inspection onto more items.
Little things in GDP include how to write, what to write, the ability to read what is required, and what does FDA expect.
Poor GDP leads to disaster. Good GDP can show the inspector that systems are in place and well managed.
In addition to how to write and where to write, a thorough discussion on how to handle raw data and where to find information.
Areas Covered in the Session: