Data Integrity Workshop Level 1 - Burlington, VT, U.S. (29-30 July 2019) $1800.00

sold out

Data Integrity Workshop Level 1 - Burlington, VT, U.S. (29-30 July 2019) $1800.00


SOLD OUT—Waiting List Only

All pricing is per person.

See information below about government employee and group rate discounts.

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Level 1: Data Integrity Assurance & Investigations of Electronic Data and Computerized Systems

Burlington, VT, U.S.

SOLD OUT—Please contact us at to be added to Waiting List

Hotel Vermont,‎

Mon, 29 July 2019 8:30am through Tue, 30 July 2019 4:30pm

This 2-day workshop provides comprehensive and highly interactive training in current regulatory expectations and industry approaches to ensuring Data Integrity and compliance with 21 CFR Part 11, with a specific focus on electronic data and computerized systems.  Example topics include:

  • Data Integrity -- Risk-Based Approach to Preventing & Detecting DI Risks

  • Data Life Cycle and Data Process Design and Controls

  • Data Integrity Governance Concepts

  • Management Governance & Quality Culture

  • Validation for Data Integrity

  • 21 CFR Part 11: Electronic Records, Electronic Signatures

  • EU Annex 11

  • Health Authorities' Data Integrity Guidances

  • Reviewing electronic data and metadata--such as audit trails

  • Risk assessment tools

  • Case study of hands-on live system audit to detect data integrity issues

  • And much more

The Level 1 workshop is designed for personnel responsible for data integrity (i.e., those who create, review and approve data in any CGxP Operational role)—as well as novice and advanced Quality & Compliance auditors, Health Authorities, System Users, IT professionals, CSV and Engineering, Management, and more. Participants will have the opportunity to discuss recent industry standards, regulations and guidances and current regulatory expectations, case studies, audit and inspection approaches, assessment tools, and FDA 483s and warning letters.  Participants will also be able to conduct a hands-on inspection of a live computerized system to detect data integrity issues and define appropriate corrective and preventative actions.  

Workshop Venue

The 29-30 July 2019 (Level 1) Data Integrity Workshopthe 31 July-01 Aug 2019 (Level 2) Data Integrity Governance, including Train-the-Trainer & Advanced Topics Workshop, and the 02 Aug 2019  (Level 3) Critical Thinking & Advanced Auditing for Data Integrity Workshop will be held at the lovely Hotel Vermont in Burlington, Vermont,, a boutique hotel centrally located in the heart of Burlington, overlooking the beautiful Lake Champlain.  A limited number of sleeping rooms have been reserved at a discounted rate for “Green Mountain Quality Assurance” of $184/night; please hurry to reserve by phoning +1 802.651.0080 or +1 855.650.0080 no later than 28 June 2019.

*Payment for more than one person: If you are submitting payment for someone other than or in addition to yourself, please be ready to send us their names and contact information with the payment using the form provided at checkout.