Data Integrity Workshop Level 1 - Copenhagen, Denmark (07-08 October 2019) $1800.00

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Data Integrity Workshop Level 1 - Copenhagen, Denmark (07-08 October 2019) $1800.00

1,800.00

All pricing is per person.

See information below about government employee and group rate discounts.

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Level 1: Data Integrity Assurance & Investigations of Electronic Data and Computerized Systems

Trainers: Monica Cahilly with Peter Baker

Copenhagen, Denmark

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

Mon, 07 October 2019 8:30am through Tues, 08 October 2019 4:30pm

This 2-day workshop provides comprehensive and highly interactive training in current regulatory expectations and industry approaches to ensuring Data Integrity and compliance with 21 CFR Part 11, with a specific focus on electronic data and computerized systems.  Example topics include:

  • Data Integrity -- Risk-Based Approach to Preventing & Detecting DI Risks

  • Data Life Cycle and Data Process Design and Controls

  • Data Integrity Governance Concepts

  • Management Governance & Quality Culture

  • Validation for Data Integrity

  • 21 CFR Part 11: Electronic Records, Electronic Signatures

  • EU Annex 11

  • Health Authorities' Data Integrity Guidances

  • Reviewing electronic data and metadata--such as audit trails

  • Risk assessment tools

  • Case study of hands-on live system audit to detect data integrity issues

  • And much more

The Level 1 workshop is designed for personnel responsible for data integrity (i.e., those who create, review and approve data in any CGxP Operational role)—as well as novice and advanced Quality & Compliance auditors, Health Authorities, System Users, IT professionals, CSV and Engineering, Management, and more. Participants will have the opportunity to discuss recent industry standards, regulations and guidances and current regulatory expectations, case studies, audit and inspection approaches, assessment tools, and FDA 483s and warning letters.  Participants will also be able to conduct a hands-on inspection of a live computerized system to detect data integrity issues and define appropriate corrective and preventative actions.  

Workshop Venue

The 07-08 October 2019 (Level 1) Data Integrity Workshopthe 09-10 October 2019 (Level 2) Data Integrity Governance, including Train-the-Trainer & Advanced Topics Workshop, and the 11 October 2019  (Level 3) Critical Thinking & Advanced Auditing for Data Integrity 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.