Explore ALCOA+, FDA observations and the failures behind data integrity findings.
THE DATAIS THERE.
BUT, CAN YOU TRUST IT?
In a regulated environment, a result is only as defensible as the data behind it.
Data integrity failures can turn routine records into regulatory findings.
BUILD DATA THAT
STANDS UP
TO SCRUTINY
Data integrity extends beyond whether a number is correct. It encompasses how data is generated, recorded, maintained, reviewed and protected throughout its lifecycle.
This workshop examines the principles and regulatory expectations behind effective data integrity programs, with lessons drawn from FDA warning letters and Form 483 observations.
01
UNDERSTAND
Explore data integrity principles, ALCOA+, and the regulatory framework behind them.
02
IDENTIFY
Recognize common causes of data integrity failures and weaknesses within existing systems.
03
PREVENT
Apply data integrity by design to build stronger, more defensible processes.
LESSONS FROM GMP INSPECTIONS
What Regulators Find...
TELLS YOU WHAT TO PREVENT.
FDA WARNING LETTERS | FORM 483s | DATA INTEGRITY FAILURES
Examine regulatory observations to understand where data integrity systems break down and how stronger controls can help prevent similar failures.
DESIGNED FOR REGULATED ENVIRONMENTS
For the people responsible
FOR THE
DATA
Quality Assurance • Regulatory Affairs • Compliance • Data Management
For professionals working with data integrity and regulatory requirements across pharmaceutical, food and cannabis environments.
