Understanding FDA and Avoiding Inspections Leading to Warning Letters, Seizures, Injunctions and Prosecutions 2013 is a conference that covers topics such as:
- How auditors think and their expectations
- FDA`s enforcement strategy and what it means to your firm
- When inspectional findings or events indicate potential regulatory actions
- Being prepared to receive regulatory inspections
- Making better responses to FDA both during and following inspections
- When to take or not immediate action during an inspection
- How to increase the effectiveness and efficiency of internal audits
- How to make written procedures and training more effective
- How to identify effective compliance metrics
Understanding FDA and Avoiding Inspections Leading to Warning Letters, Seizures, Injunctions and Prosecutions 2013 brings together:
- Individuals who come in contact with regulatory inspectors
- Managers responsible for GMP compliance and seeking a better understanding of FDA, inspections, regulatory actions and how they can improve their own firm`s operations and monitoring of their state of GMP compliance
- Compliance/Regulatory affairs professionals
- Auditors
- Senior management executives (CEO, COO, CFO, etc.)
- QA/QC professionals
- Project Managers
- Manufacturing managers, supervisors & personnel
- Consultants
