Current and Future Technologies to Assist in Compliance and Computer Validation for GxP Systems


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Waters’ experts will illustrate the challenges of keeping computerized systems which are critical to regulatory compliance, under control. The CDRH Medical device group at FDA, are drafting an update for their guidance on computerized system validation. Primarily this is to promote a smarter risk-based approach to encourage the life science industry to adopt new technologies and automation opportunities, while remaining in compliance with regulations. How could a fresh look at available technology be used to innovate how such systems are deployed, allowing them to be regularly updated without creating a significant validation burden? Live: Thursday, Oct. 3, 2019 at 10am EDT | 9am CDT | 3pm BST | 4pm CEST On demand available after airing until Oct. 3, 2020 Register free

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Event Overview:
Ensuring data created, modified, reported and managed in electronic systems meet regulatory expectations requires detailed planning, documentation and testing. As regulations for electronic data evolve to demand more controls, a deeper understanding is needed about the insights electronic data can bring to assure Data Integrity. Technology is also advancing which may provide automated solutions for these challenges.

In this webcast, data integrity subject matter experts will share knowledge and techniques including:

  • The challenges of managing data that support clinical studies, pharmaceutical development or manufacturing batch records, including selecting the right software applications, as well as deploying, configuring and validating those alongside your SOPs for use

  • Leveraging your expert vendor to minimize the effort

  • Future technology solutions that could reduce manual efforts to ensure compliance:
  • Automation

  • AI and machine learning to mine data

  • Blockchain

  • Cloud deployment strategies

  • Containers

  • Long term archiving and vendor-neutral data formats

Key Learning Objectives:

  • Appreciate the manual paper-based processes needed today to ensure compliance and a validated state for computerized systems in regulated environments

  • Look for the quick wins to apply a risk-based approach to compliance, validation and change control

  • Learn about how computing technology could help reduce compliance and validation concerns as software applications transform

Speakers: Clive Higgins, Informatics Product Marketing Manager, Waters Corporation

Heather Logden, Pharmaceutical Regulatory Intelligence, Waters Corporation

Time and Date: Thursday, Oct. 3, 2019 at 10am EDT | 9am CDT | 3pm BST | 4pm CEST

On demand available after airing until Oct. 3, 2020

Sponsor: Waters Corporation

Register free:

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