Data Integrity Workshop Level 2 - La Jolla, CA, US (27-28 February 2019) $1600.00

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La Jolla.JPG

Data Integrity Workshop Level 2 - La Jolla, CA, US (27-28 February 2019) $1600.00

1,600.00

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

La Jolla, CA, U.S.

La Valencia Hotel, http://www.lavalencia.com/

Wed, 27 February 2019 8:30am through Thu, 28 February 2019 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 data integrity governance program, including:

  • Management Governance & Quality Culture that Fosters Data Integrity Assurance and Innovation
  • Quality Risk Management and Risk-Based Data Integrity Governance Plans
  • The Potential Power and Pitfalls of Metrics
  • Considerations for a CGxP "Data Science" Program
  • Data Process Mapping & Aligning "Data Life Cycle" with QbD and QRM across the Product Life Cycle
  • Organizational Roles and Responsibilities
  • Integrating Ethics into CGxP 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
  • Advanced Computing Highlights--Hybrid Validation Models & Cloud Systems
  • 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 the following roles: Senior Quality and Management; those establishing and managing Data Integrity Governance Programs, Quality Auditors and Health Authorities; 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 25-26 February 2019 (Level 1) Data Integrity Workshopthe 27-28 February 2019 (Level 2) Data Integrity Governance, including Train-the-Trainer & Advanced Topics Workshop, and the 01 March 2019 (Level 3) Critical Thinking & Advanced Auditing for Data Integrity Workshop will be held will be held at the lovely La Valencia Hotel in La Jolla, California, http://www.lavalencia.com/ a vintage boutique hotel and spa situated atop La Jolla Cove, overlooking the beautiful Pacific Ocean.  A limited number of sleeping rooms have been reserved at a discounted rate for “Green Mountain Quality Assurance” of $259/night; please hurry to reserve by phoning +1 800.451.0772 or +1 858.454.0771 no later than 29 January 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.