Data Integrity Workshop Level 3 - New Jersey (22 November 2019)


Data Integrity Workshop Level 3 - New Jersey (22 November 2019)


All pricing is per person.

See information below about government employee and group rate discounts.

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Level 3: Critical Thinking & Advanced Auditing for Data Integrity

Basking Ridge, New Jersey (30 minutes from EWR airport)

Olde Mill Inn,

Friday, 22 November 2019, 8:30am through 4:30pm

This 1-day workshop provides the opportunity to interact and share ideas with other experienced GxP personnel in small-group, hands-on inspection case study exercises as each team applies their data integrity inspection skills in mock inspection scenarios.  Highlights include:

  • Critical Thinking Skill Development Exercises

  • Small Group Mock Inspection Exercises

  • Inspecting Live Computer Systems for Data Integrity Controls

  • Pivot Tables of Data Exports

  • Pattern Recognition Exercises

  • Interviewing Techniques

  • Flags for Parallel Record-Keeping

  • Recovering Deleted Data

  • Evaluating Data Governance Programs

  • Data Process Maps and Data Life Cycle Assessments

  • Writing Responses to Data Integrity-Related Health Authority Observations

  • Evaluation of Current Enforcement Trends, including FDA & EU citations

  • Experience sharing and discussions among experienced auditors: "What has worked best?"

  • More Case Studies

The Level 3 workshop is designed for personnel who have completed the GMQA Level 1 and Level 2 workshops and have a minimum of 5 years of GxP experience.  The Level 3 workshop may be of particular interest to Quality Auditors, Health Authorities; as well as personnel responsible for establishing and managing Data Integrity Compliance Programs / GxP Data Governance Programs and Quality Risk Management; Management Governance and Knowledge Management program teams; personnel responsible for establishing Data Integrity Training Programs; Information Technology and Computer Validation personnel, as well as personnel in Operational roles preparing for data integrity inspections. 

Workshop Venue

The 22 November 2019 (Level 3) Critical Thinking & Advanced Auditing for Data Integrity Workshop will be held at the historic Olde Mill Inn in Basking Ridge, New Jersey, a boutique hotel centrally located in New Jersey, near the charming villages of Bernardsville, NJ and Basking Ridge, NJ.  The Olde Mill Inn, in the lovely Somerset Hills of the "Garden State", is only a short 30-minute drive from the Newark (EWR) airport, a 1-hour drive from New York City, and easily accessible on the NJ Transit Train line. A limited number of sleeping rooms have been reserved at a discounted rate for “Green Mountain Quality Assurance” of $210/night; please hurry to reserve by phoning +1-800-585-4461 or +1-908-221-1100 no later than 03 November 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 when adding workshops to your cart.