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Join us the day before the FDA/Xavier PharmaLink conference, for the Data Integrity Master Class,Tuesday, March 13, 2018,from 8am-4pm, at Xavier University. John Avellanet,who trains the FDA on how to find data integrity issues in companies worldwide, will provide answers, examples and steps to taketodayto reduce your risk to your company, products, and patient.
Register today for this very interactive class, which includes:
- Two full case studies – includinga firm that had previously passed nine different inspections since 2000
- Exercises where you play the role of the FDA investigator
- Multiple structured questions throughout
KEY TAKEAWAYS
- Specific regulatory citations and requirements, and critical guidance documents to master
- Example FDA inspection questions to prepare for around data integrity
- How FDA holds you accountable for your suppliers' data integrity during an inspection
- Eight practical elements of a compliant, risk-based data integrity program
- The key roles of senior management, IT, records management, and quality
- Specific SOPs and policies you need, or will need, to improve to meet the latest expectations
- Rapid techniques to incorporate risk-based decisions and priorities into your overall plan in a way that will pass inspection
- Specific data integrity-related documents you must have available for regulators
