Data Integrity Workshop Level 4 - New Jersey (18-19 November 2019)

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Data Integrity Workshop Level 4 - New Jersey (18-19 November 2019)

1,800.00

All pricing is per person.

See information below about government employee and group rate discounts.

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Level 4 Workshop: Forensic Review and Investigative Techniques to Identify Data Integrity Risks

Trainer: Peter Baker

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

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

Monday-Tuesday, 18-19 November 2019, 8:30am to 4:30pm

This 2-day workshop provides the unique opportunity to learn valuable forensic review and investigative / inspection-readiness techniques from a former FDA Drug Investigator with globally-recognized expertise in data integrity investigations. In this workshop, you will have the chance to 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, building upon the learnings from Level 3 and providing additional case studies in preparation for a ‘Data Integrity Auditor’ qualification exam.  Highlights include:

  • Detecting Patterns in Analytical Data

  • Detecting Potential Falsification During Paper-Based Reviews

  • Remote Review of Records with an Eye for Breaches in Data Integrity

  • Evaluating Quality Culture and What It All Means

  • Advanced Interviewing Techniques

  • Detecting Data Integrity Risks in the Manufacturing Environment

  • Aspects of an Effective Six-System Risk-Based Inspection

  • Preparing Responses to Data Integrity-Related Health Authority Observations

  • More Case Studies

The Level 4 workshop is taught by Peter Baker, former FDA Drug Investigator, with specialized global expertise in data integrity investigations. This workshop is designed for experienced personnel who have completed the GMQA Levels 1 through Level 3 workshops and have a minimum of 5 years of GxP experience.  The Level 4 workshop may be of particular interest to Quality Auditors, including Forensic Auditors, as well as personnel from all-functions responsible for preparing for Health Authority inspections and responding to data integrity-related observations.  

Workshop Venue

The 18-19 November 2019 (Level 4) 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 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 at checkout.