Data Integrity Workshop Level 1 - Cork, Ireland (01-02 April 2019) $1600.00

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Data Integrity Workshop Level 1 - Cork, Ireland (01-02 April 2019) $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

Cork, Ireland

The River Lee Hotel, https://www.doylecollection.com/hotels/the-river-lee-hotel

Monday, 01 April 2019 8:30am through Tuesday, 02 April 2019 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

  • EC 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 April 2019 (Level 1) Data Integrity Workshop and the 03-04 April 2019 (Level 2) Data Integrity Governance, including Train-the-Trainer & Advanced Topics Workshop and the 05 April 2019 (Level 3) Critical Thinking & Advanced Auditing for Data Integrity will be held will be held at The River Lee Hotel in Cork, Ireland,  https://www.doylecollection.com/hotels/the-river-lee-hotel a boutique hotel situated in Cork’s historical city center with easy access to central Cork’s museums, shopping, and lively pubs. 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 189€/night single or 199€/night double occupancy Classic Room with full Irish breakfast or upgrade to Deluxe King Room for an additional 50€/night; please hurry to reserve by phoning +353 21 493 7706 or by completing this registration form no later than 14 February 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.