2019 - Auditing API Facilities: A MUST to properly prepare for an FDA Regulatory API GMP Inspection

Discusses what will be covered during this program
What is the most critical understanding needed for success
Suggested process to follow including: what to review before and during the audit
What and where to look
No smoking guns observed
No Data Integrity Issues Observed
Review all appropriate areas including Critical Operations/Systems/Records
How the Audit should Start and End
Where are the key areas and systems
Opening/Ending/ and Follow-up Actions to the Audit