fda 483

Clinical Research Solutions

What Should Be on Your Clinical Trial Investigator Site Audit Checklist?

What Should Be on Your Clinical Trial Investigator Site Audit Checklist?: You live and operate in a regulated industry. Obviously, it’s crucial that you stay in compliance during your clinical...

Quality & Compliance

The Investigation Best Practices to Avoid FDA 483 Observations

For a number of years, discrepancy and failure investigations within the pharmaceutical industry have been populating the Top 3 of a Food and Drug Administration (FDA) Observation list....