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Risk Assessment in GxP Environments

Risk Assessment in GxP Environments
Webinar: Risk Assessment in GxP Environments

​​​​​​​The regulatory environment regarding controlled temperature storage of Life Science product is changing quickly. New or revised regulations have been released in India, Europe, Canada, and the USA recently. These changes increase the breadth of the supply chain that is regulated. In short, more players need to show compliance, and they need to do a thorough job of it. 

In this webinar, our Senior Regulatory Expert Paul Daniel shows you techniques to assess risk in GxP environmental monitoring systems. These tools will allow you to more accurately determine the validation requirements of computerized systems and make your software validation workload more manageable. Paul also discusses how to justify your methods with appropriate rationales.

Key Learning Objectives​

  • ​Introduction to risk assessment methods and techniques
  • Understand the process and goals of assessing risk
  • Show examples from Vaisala Continuous Monitoring System

Target Audience

  • ​Regulatory Managers
  • Metrology Managers
  • Quality Managers
  • Validation Managers
  • Facility Managers
  • Stability Managers
  • Warehouse Managers
  • Laboratory Managers
  • Logistics Managers
  • R & D Managers
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Paul Daniels

Paul Daniel,
Sr. Regulatory Compliance Expert

Paul Daniel is Senior Regulatory Compliance Expert at Vaisala. He has fifteen years of validation experience in the pharmaceutical and medical device industries. He has worked on a wide range of qualification projects, including process, cleaning, shipping, laboratory equipment, packaging, software, network and computer validation. He has an extensive practical grounding in applying the GMP principles found in 21 CFR Parts 11, 210, 211, and 820. His specialties include: authoring and executing validation protocols (IQ and OQ) for pharmaceutical manufacturing and software validation with a risk-based approach drawn from GAMP guidelines.

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