Data Integrity Workshop Level 1 - New Jersey (12-13 November 2018)

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Data Integrity Workshop Level 1 - New Jersey (12-13 November 2018)

1,600.00

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

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

Olde Mill Inn, https://www.oldemillinn.com/ 

Mon, November 12, 2018 8:30am through Tue, November 13, 2018 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, including:

  • Data Integrity -- Risk-Based Approach to Preventing & Detecting
  • Data Life Cycle Design and Controls
  • Validation for Data Integrity
  • 21 CFR Part 11: Electronic Records, Electronic Signatures
  • EU Annex 11
  • CGXP Requirements for Data Integrity, including Current Health Authority Data Integrity Guidances
  • Data Integrity Compliance Plans and Accountability Structures
  • Techniques to Identify and Investigate Aberrant Data Patterns
  • 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 GxP 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.  Attendees will also be able to participate in a hands-on inspection of a live computerized system to detect data integrity issues and define appropriate corrective and preventative actions.  

Workshop Venue

The 12-13 November 2018 (Level 1) Data Integrity Workshop will be held will be held at the historic Olde Mill Inn in Basking Ridge, New Jersey, https://www.oldemillinn.com/ 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 30 October 2018.

*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.