*NEW* Data Integrity Workshop Level 4 - Copenhagen, Denmark (07-08 October 2019) $1800.00


*NEW* Data Integrity Workshop Level 4 - Copenhagen, Denmark (07-08 October 2019) $1800.00


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

Copenhagen, Denmark

Hotel SKT Petri, https://www.sktpetri.com/

Monday-Tuesday, 07-08 October 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 07-08 October 2019 (Level 4) Forensic Review and Investigative Techniques to Identify Data Integrity Risks Workshop will be held at the lovely Hotel SKT Petri in Copenhagen, Denmark, https://www.sktpetri.com/. This boutique hotel in the heart of Copenhagen’s old Latin quarter, just a short bus ride from the Tivoli Gardens. A limited number of sleeping rooms have been reserved at a discounted rate of DKK 1595/night for a Superior Single Room which includes breakfast; cite booking code “GREEN” when making your reservation. Please hurry to reserve by phoning +45 33 45 91 00  or online at sktpetri.com using the above discount code no later than 6 September 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.