Data Integrity Workshop Level 1 - Amsterdam (01-02 October 2018) $1600.00

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amsterdam-canal-tulips.jpg

Data Integrity Workshop Level 1 - Amsterdam (01-02 October 2018) $1600.00

1,600.00

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

Amsterdam, The Netherlands

Kimpton De Witt Hotel, http://www.kimptondewitthotel.com/

Mon, 01 October 2018 8:30am through Tue, 02 October 2018 4:30pm

This 2-day workshop provides comprehensive and highly interactive training in current regulatory expectations and industry approaches to assuring Data Integrity, with a specific focus on Electronic Data and Computerized Systems and compliance with 21 CFR Part 11, including:

  • Data Integrity -- Risk-Based Approach to Preventing & Detecting
  • Data Life Cycle Design and Controls
  • Validation for Data Integrity
  • 21 CFR Part 11: Electronic Records, Electronic Signatures
  • EU Annex 11
  • CGXP Requirements for Data Integrity, including Current Health Authority Data Integrity Guidances
  • Data Integrity Compliance Plans and Accountability Structures
  • Techniques to Identify and Investigate Aberrant Data Patterns
  • 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 GxP 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 01-02 October 2018 (Level 1) Data Integrity Workshop and the 03-04 October 2018 (Level 2) Data Integrity Governance, including Train-the-Trainer & Advanced Topics Workshop and the 05 October 2018 (Level 3) Critical Thinking & Advanced Auditing for Data Integrity will be held will be held at the lovely Kimpton De Witt Hotel in Amsterdam, The Netherlands, http://www.kimptondewitthotel.com/. This boutique hotel is situated in heart of Amsterdam Palace Quarter, with easy access to Amsterdam's City Centre, historical canals, and lively cafes. 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 239€/night single room with breakfast; please hurry to reserve by the following booking link (Kimpton Hotel Booking) or phoning +31 (0) 20 52 11 852 no later than 01 September 2018.

*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.