Northern VA Information Provider Launches 12th Publication For Pharmaceutical and Medical Device Industry Executives
FALLS CHURCH, Va., Aug. 10 /PRNewswire/ -- FDAnews, a leading provider of compliance information for companies regulated by the U.S. Food and Drug Administration, today announced the launch of Part 11 Compliance Report, the first newsletter to focus solely on the critical issues surrounding FDA's regulation for electronic records and electronic signatures. FDA has issued complex rules, known as Part 11, stipulating how regulated companies create, validate, store, access and change computerized records. "Part 11 affects nearly every computer system related to laboratory and clinical trials and manufacturing," explained Cynthia A. Carter, president. The value of all the systems that need to be brought into compliance with the rule runs well into the billions of dollars. Subscribers to Part 11 Compliance Report will get: 1) in-depth reviews and interpretations of FDA's Part 11 rule and forthcoming guidance documents so you can avoid expensive changes to systems, procedures and documentation 2) best practices in implementation and real examples of how individual companies are tackling specific compliance challenges: electronic submissions, user ID codes, data security, data management, audit trails 3) detailed reports of enforcement activity to learn what FDA is cracking down on 4) exclusive interviews with leading regulators, attorneys, consultants and practitioners Part 11 Compliance Report is produced by FDAnews, a division of Washington Business Information, Inc. FDAnews also publishes Washington Drug Letter, Generic Line, Devices & Diagnostics Letter, Strategic Outsourcing Report, Drug Marketing, Europe Drug & Device Report, the FDAnews Daily Bulletin an electronic briefing, books, special reports and conferences, and many other information services to help pharmaceutical and medical device executives meet their regulatory challenges. SUBSCRIPTION INFORMATION: Frequency: Biweekly (24 issues), with email alerts Format: Print and electronic Price: $627/year Editor: Peter Riebling For more information contact: FDAnews at 888-838-5578 or 703-538-7600 or visit us at: http://www.fdanews.com/. MAKE YOUR OPINION COUNT - Click Here http://tbutton.prnewswire.com/prn/11690X43046622
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