Using IT to Improve Data Integrity
Optimizing Your Compliance Joint IT/QA Programs

Friday, Sept. 27, 2019 • 11:00 a.m. – 12:30 p.m. EDT

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.

Mark your calendar 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.

Webinar Takeaways:

  • 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.

Who Will Benefit

From the C-suite to specialized professionals, executives in FDA-regulated health science companies across the board will benefit from this timely Web-based learning session. Specific job titles include but are not limited to—

  • Executive management
  • Quality executives
  • R&D
  • Compliance/Regulatory
  • Manufacturing
  • Auditors
  • PMOs
  • Clinical
  • Data management/statistics
  • Engineering/design control
  • Legal counsel
  • Consultants/service providers
  • Recent hires

Webinar plus USB Audio Recording/Transcript
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24/7 Encore plus USB Audio Recording/Transcript
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Meet Your Presenter

Israel Heskiel

Agrei Consulting

For more than 20 years, consultant Israel Heskiel has focused on easing companies like yours into the new world of IT data integrity. Clients have included Fidelity Investments, Estee Lauder Companies, AON, WPP, Bank of New York and health science manufacturers. In this session he will pinpoint compliance with the FDA's Data Integrity Title 21 Part 11, and the Final Guidance on Data Integrity and Compliance with Drug cGMP.

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