Auditing API Facilities: A MUST to properly prepare for an FDA Regulatory API GMP Inspection 2019 is a webinar that covers topics such as:
- What is the most critical understanding needed for success
- Discusses what will be covered during this program
- What and where to look
- Suggested process to follow including: what to review before and during the audit
- No Data Integrity Issues Observed
- No smoking guns observed
- How the Audit should Start and End
- Review all appropriate areas including Critical Operations/Systems/Records
- Opening/Ending/ and Follow-up Actions to the Audit
- Where are the key areas and systems
Auditing API Facilities: A MUST to properly prepare for an FDA Regulatory API GMP Inspection 2019 is intended for:
- Manufacturing
- Quality
- Distribution
- Engineering
- Key personnel
- Regulatory management
