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Modern Rules for an Old Practice: Sensor Placement for GxP Environments

Modern Rules for an Old Practice: Sensor Placement for GxP Environments
A 1-hour training in five best practices for performing temperature mapping studies

​​​The regulatory environment regarding controlled temperature storage of life science products is changing quickly. New or revised regulations have been released in India, Europe, Canada, and the USA. These changes have increased the breadth of the supply chain that is regulated.

Temperature mapping is a key strategy used in GxP-regulated environments to demonstrate the temperature uniformity necessary for safe storage of products. With new regulations, mapping studies are often performed (or reviewed) by people who are new to mapping. With more companies than ever needing to perform mapping studies to demonstrate understanding of their environments, it's more important than ever before to have clear guidelines and best practices for sensor placement.

This webinar teaches sensor placement in 5 simple rules. These rules are presented in a simple mathematical format that will allow anyone with limited experience with mapping studies to effectively determine proper sensor placement for a study. We will also discuss the regulations and recently published guidance to demonstrate suitability and relevance of the 5 rules. 

If you are new to mapping studies, or if you train individuals unfamiliar with the practice, these rules are invaluable information for you...

Key Learning Objectives​

  • ​Review the global regulatory changes and guidance on GDP from: CFDA, EMA, USP36 Chapter <1079>, CDSCO, PDA, ISPE etc.
  • Learn the "5 Rules" of mapping to ensure that storage spaces are controlled to meet specifications.
  • Review the many factors that will impact sensor placement
  • Undertand how to create an effective ratio of sensor to area for mapping

Target Audience

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

Paul Daniel,
Sr. Regulatory Compliance Expert

Paul Daniel is Senior Regulatory Compliance Expert at Vaisala. He has eighteen years of validation experience in 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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