Notification of an FDA inspection creates concern that all processes are adequate to meet stringent standards. Even the best-prepared companies can still have a moment of doubt that their best-laid plans have left out a critical component.
EAS Consulting Group’s Pre-FDA Inspection Seminar – Preparation, Validation, Qualification helps companies prepare for an FDA inspection before FDA walks through the door. Our team of experts, former FDA compliance and inspection officials and industry executives, prepares your in-house experts on the detailed analyses and checks that FDA will be combing through to ensure all applicable requirements are being met or exceeded.
In this seminar you will:
- Understand what to expect in an FDA inspection
- Take a close look at your processes, systems, and procedures to ensure you are meeting FDA requirements and developing an improvement plan in advance of the inspection for those items that do not
- Understand the what’s and how’s of qualification and how to ensure results are appropriately validated
- Understand how best to collect and track adverse events reporting
- Set-up internal documentation structures so that FDA may easily access required information
- Discuss 483 Warning Letters and required responses