Simplifying Global Compliance
Managing Data and Documentation for FDA Inspections
Quantity Discounts 1 - 2 $397.00 3 - 4 $357.00 5 - 6 $337.00 7 - 9 $317.00 10 - 9999 $297.00
Managing Data and Documentation
for FDA Inspections
Do you understand the FDA’s document access authority? Is your company’s data and documentation organized and ready for your next FDA inspection?
If not, your next inspection could become a scavenger hunt.
Managing Data and Documentation for FDA Inspections will help you get control of your data by using industry best practices and SOPs.
You will also learn:
Documentation the FDA is entitled to see;
Documentation the FDA is not entitled to see;
How to create unique naming conventions to handle masses of data;
How to prioritize data that might be requested during an inspection;
The “Top 10” questions to ask about your archival process;
What to do when documents are not in the general archives;
When does email count as documentation;
If source data is electronic, how to provide access to the regulatory authority;
If source data is paper that was scanned, what to do with the originals; and
Tips for dealing with more than one “original.”
Order Your Copy Today!
PDF Edition — $397
Table of Contents
The FDA’s Document Access Authority
And More …
View the entire TOC
Who Will Benefit
QA/QC managers and staff
Document managers and staff
Regulatory affairs managers and staff
IT managers and staff
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