*NEW* Data Integrity Workshop Level 4 - Dublin (18-19 February 2020)


*NEW* Data Integrity Workshop Level 4 - Dublin (18-19 February 2020)


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

Dublin, Ireland

The Gibson Hotel, http://www.thegibsonhotel.ie

Monday-Tuesday, 18-19 February 2020, 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 10-11 February 2020 (Level 1) Data Integrity Workshop and the 12-13 February 2020 (Level 2) Data Integrity Governance, including Train-the-Trainer & Advanced Topics Workshop and the 17 February 2020 (Level 3) Critical Thinking & Advanced Auditing for Data Integrity and the 18-19 February 2020 (Level 4) Forensic Review & Data Integrity Investigative Techniques Workshop will be held will be held at the lovely Gibson Hotel in Dublin, Ireland,  http://www.thegibsonhotel.ie/ a boutique hotel situated in Dublin’s new cultural center with easy access to the airport and the vibrant Dublin nightlife. A limited number of sleeping rooms have been reserved at a discounted rate for the “Data Integrity Workshops / Green Mountain Quality Assurance” conference rate of 130€/night single room with full Irish breakfast or 145€/night double room with full Irish breakfast; please hurry to reserve by emailing reservations@thegibsonhotel.ie or phoning +353 (0)1 681 5053 and ask for the “Green Mountain Quality Assurance” rate no later than 20 January 2020.

*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.