Day One Agenda
| Session 1 |
Examine the Approval Process and Pre-Approval Inspection Program |
| Session 2 |
Identify the FDA’s expectations for Drug Establishments |
| Session 3 |
Analyze Major Elements Covered During the PAI |
| Session 4 |
Overcome Common Documentation Obstacles |
| Session 5 |
Establish and Maintain Self- Audit Programs to Ensure Preparedness |
| Session |
Day One Training Concludes |
Day Two Agenda
| Session 7 |
Quality Assurance in the Laboratory |
| Session 8 |
Managing Vendors and Suppliers |
| Session 9 |
The Best Documentation Practices |
| Session 10 |
Dealing with Non-Conformances, Deviations & Complaints |
| Session 11 |
Reviewing Batch Records |
| Session 12 |
Examine and Evaluate: Statistics and Control Charts |
| Session 13 |
Assess Current Regulatory Activity |