Optimizing Your Compliance Joint IT/QA Programs Webinar, Sept. 27, 2019


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Using IT to Improve Data Integrity

Optimizing Your Compliance Joint IT/QA Programs

**An FDAnews/CenterWatch Webinar**

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

https://www.fdanews.com/itdataintegrity

Who should be a key member of the data integrity team?

The IT department.

Don’t let IT become an afterthought in the data integrity effort. With the increase in digitized records one of the key team members is IT.

The success of the next inspection could depend on the technological component of data integrity. So here’s what to do …

Mark the calendar for Friday, Sept. 27, when data management guru Israel Heskiel shows attendees how to close the gap between IT and the rest of the team. Mr. Heskiel boasts more than 20 years of IT leadership. Over 90 fast-paced minutes, attendees will learn the path to compliance with FDA Data Integrity Title 21 Part 11 in the organization. Prepare to discover:

  • 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 one learns what FDA investigators will look for vis-à-vis an integrated systems approach
  • Creating an “FDA audit IT SWAT team” for continuous improvement


Due for an inspection? Got a 483 observation or warning letter to remedy? Attend this session.

Interested in registering multiple sites?

Call (888) 838-5578 in the U.S. or +1 (703) 538-7600 globally to learn about our special multisite discount.

Webinar Details:

Using IT to Improve Data Integrity

Optimizing Your Compliance Joint IT/QA Programs

**An FDAnews/CenterWatch Webinar**

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

https://www.fdanews.com/itdataintegrity

Tuition: $287 per site

Easy Ways to Register:

Online: https://www.fdanews.com/itdataintegrity

By phone: 888-838-5578 or 703-538-7600

About FDAnews:

FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews’ print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA’s complex and ever-changing regulations.

About CenterWatch:

Founded in 1994, CenterWatch is a trusted source and global destination for clinical trials information for both professionals and patients. CenterWatch provides proprietary data and information analysis on clinical trials through a variety of newsletters, books, databases, and information services used by pharmaceutical and biotechnology companies, CROs, SMOs, and investigative sites involved in the management and conduct of clinical trials. As a pioneer in publishing clinical trials information, CenterWatch was the first Internet site to publish detailed information about active clinical trials that could be accessed by patients and their advocates.

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