Using IT to Improve Data Integrity – Webinar Recording/Transcript
Using IT to Improve Data Integrity: Optimizing Your Compliance Joint IT/QA Programs
Is IT a fully vested member of your data integrity team? The success of your next inspection could depend on it.
But many firms — yours among them, perhaps — haven’t fully brought the IT folks onto the team. Now comes FDAnews with an all-new webinar to help solve this problem ... before the inspectors’ next visit.
Join us for a 90-minute crash course with consultant Israel Heskiel on integrating IT into the overall data-integrity compliance effort. Mr. Heskiel boasts more than 20 years of IT leadership.
- Communicating with IT leaders about IT’s role in data integrity compliance
- Establishing SOPs: Getting IT, QA, Supply Chain and R&D on the same page
- IT, quality management and regulatory affairs: Scaling for speed and efficiency under the Final Guidance on Data Integrity and Compliance with Drug cGMP
- Mock FDA data integrity audit: Here’s where you learn what FDA investigators will look for vis-à-vis an integrated systems approach
- Creating an “FDA audit IT SWAT team” for continuous improvement
Perhaps you’re expecting a visit from the inspectors soon. Perhaps you have a 483 observation or warning letter to remedy. Or maybe you’re merely concerned about taking the next step into a more efficient data-managed future. Regardless, this session is geared to help you meet your goals.