Data Integrity Workshop Level 2 - New Jersey (14-15 November 2018)

Grain-House-Eco-Meeting-on-Hunt-Patio.jpg
Grain-House-Eco-Meeting-on-Hunt-Patio.jpg

Data Integrity Workshop Level 2 - New Jersey (14-15 November 2018)

1,600.00

All pricing is per person.

See information below about government employee and group rate discounts.

Quantity:
Add To Cart

Level 2: Data Integrity Governance Programs, including Train-the-Trainer & Advanced Topics

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

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

Wed, 14 November 2018 8:30am through Thu, 15 November 2018 4:30pm

This 2-day workshop builds upon the materials covered in the Level 1 “Data Integrity Assurance” workshop and provides more in-depth material, advanced topic discussions, additional case studies, and tools and discussions to build an effective internal training program to assure data integrity and inspection-readiness, including:

  • Management Governance & Quality Culture that Fosters Data Integrity Assurance and Innovation
  • Quality Risk Management and Risk-Based Data Integrity Plans
  • The Potential Power and Pitfalls of Metrics
  • Building a GxP Data Governance and "Data Science" and "Data Analytics" Program
  • Data Process Mapping & Aligning "Data Life Cycle" with QbD and QRM across the Product Life Cycle
  • Organizational Roles and Responsibilities
  • Integrating Ethics into GxP Compliance and Quality Systems
  • Incentivizing Data Integrity and Operational Excellence
  • Train-the-Trainer: Developing and Implementing a Data Integrity Training Program
  • "Critical Thinking" Skills Development Exercises for Quality Auditors
  • Integrating Data Integrity into Supplier Management: Quality Agreements and Data Monitoring
  • Experience sharing and discussions among experienced data integrity compliance teams: "What has worked best?"
  • More Case Studies

The Level 2 workshop is designed for personnel who have completed the GMQA Level 1 workshop and are interested in more in-depth coverage of the subject material, including more applied learnings through case studies and small group activities.  The Level 2 workshop may be of particular interest to those in Senior Quality and Management roles; those establishing and managing Data Integrity Compliance Programs / GxP Data Governance Programs, Quality Auditors and Health Authorities; Quality Risk Management and 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 14-15 November 2018 (Level 2) Data Integrity Governance, including Train-the-Trainer & Advanced Topics Workshop 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.no later than 10 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.