Develop and Validate Excel Spreadsheets for 21 CFR Part 11 Compliance: Live Webinar by AudioEducator

04:05 EDT 9 Aug 2017 | PR Web

This live webinar will help manufacturers of drugs, biologics, biosimilars and medical devices comply with the FDA’s electronic records regulations.

Durham, NC (PRWEB) August 09, 2017

AudioEducator, a division of audio conference and corporate education leader ProEdTech, will host the live webinar “Excel Spreadsheets: Develop and Validate for 21 CFR Part 11 Compliance” with industry veteran Dr. David Lim on Wednesday, August 23, 2017 at 1:00 pm ET. This session will provide tips to assist manufacturers of drugs, biologics, biosimilars and medical devices in developing and auditing Excel spreadsheets for 21 CFR Part 11 compliance.

Under 21 CFR Part 11, the FDA’s main regulation of electronic records and signatures, drug and device manufacturers must validate the computer software they use in their quality control systems in order to ensure the accuracy and confidentiality of electronic data they’re required to maintain. Using Excel is one of the main ways that firms maintain that data. As part of their compliance efforts, pharmaceutical and device manufacturers must check current practices and implement proper procedures in this key risk area in order to avoid expensive and burdensome enforcement actions by the FDA.

In this session, expert speaker Dr. David Lim, Ph.D., RAC, ASQ-CQA, will explain how to develop and implement Part 11 and Excel spreadsheet computer system validation. Providing practical advice and examples, David will discuss all applicable definitions and compliance requirements for Excel spreadsheets under 21 CFR Part 11 and other federal statutes and regulations. He will specifically cover how to maintain this data for the purposes of good practices (GxP) compliance.

This session will help pharmaceutical and device company CEOs, VPs, compliance officers and other healthcare professionals learn about:

  •     Compliance requirements for Excel spreadsheets under 21 CFR Part 11
  •     Other applicable statutes and regulations
  •     Excel spreadsheets for GxP data
  •     Protecting Excel spreadsheets
  •     FDA enforcement actions relating to Excel spreadsheet maintenance
  •     How to avoid FDA 483s and warning letters
  •     Excel and computer system validations
  •     Excel data validations
  •     Implementing Excel audit trails
  •     Excel validation documentation requirements
  •     PASS-IT recommendations and best practices

For more information and to register, visit:

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About ProEdTech

ProEdTech is a leading source of knowledge and training for professionals in over 15 industries, serving individuals, businesses and their employees around the globe. It offers webinars, online conferences, seminars, boot camps, books, DVDs, white papers, industry reports and other learning tools from industry experts and insiders who provide a fresh perspective on key issues, trends and regulations in order to simplify governance, risk and compliance (GRC) for enterprises and industry professionals.

ProEdTech’s AudioEducator webinars offer updates, regulatory knowledge and information on the latest news in various medical specialties, as well as coding and billing updates, and analysis of regulations that affect ambulatory surgical centers, home health, long term care and hospice facilities, hospitals and healthcare systems, health insurers and physician practices. Webinars are also offered through AudioSolutionz in the technology, human resources, construction and housing, ICT and telecom, manufacturing, consumer packaged goods and retail, safety and security, transportation, energy and environment, education, trade, and chemicals industries. ProEdTech’s Eli Financial platform offers tax and banking professionals, focusing on providing high-quality online training products customized for U.S. lenders and tax practitioners that include the latest updates from the IRS, CFPB and other regulatory authorities. Lawyers across the United States depend on Eli CLE for top quality online continuing legal education (CLE) programs, which can be completed for MCLE credits.

ProEdTech regularly provides professionals the opportunity to get answers to their most complex questions directly from experts, without having to attend costly live conferences. To learn more, visit:

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