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Data Integrity in Pharmaceutical Environmental Monitoring - Beyond Bytes and Signatures

Data Integrity for Pharmaceutical GxP Software
Data Integrity in Pharmaceutical Environmental Monitoring - Beyond Bytes and Signatures
In this webinar you will learn how to maintain data integrity in environmental monitoring applications. Participants will get an up-to-date overview of the current regulatory expectations for practices that ensure data integrity.


All systems that record information for GxP-regulated applications — be they manual, automatic or hybrid — have inherent data integrity risks.  Data integrity is not a novel regulatory requirement, but compliance failures and enforcement actions are becoming more common as regulatory scrutiny increases. With globalization and increasing use of digital information with computerized systems, several new regulatory guidance documents have recently been published to clarify how data should be recorded, processed, stored and retrieved.

However, good data integrity is about more than compliance with regulations. In life science applications, data often represents a significant investment in research, development, samples or donated tissue. In life science, data can also represent the hope of patients for a novel therapy or drug. As in all other aspects of regulated industry applications, these processes require  trustworthy systems to ensure patient safety.

Join in this webinar and learn how to maintain data integrity in environmental monitoring applications. Along with best practices for managing environmental data, participants will get an up-to-date overview of the current regulatory expectations for practices that ensure data integrity. Plus, we enjoy a lively Q&A session at the end of the webinar.

Key Learning Objectives:

  • Review of recent guidance and documents
  • Learn how to evaluate data integrity risks
  • Discuss common pitfalls of data management in GxP applications
  • Review best practices for ensuring and preserving data integrity

Who Should Attend:

  • Regulatory Officers
  • Metrologists
  • Quality Managers (QA/QC)
  • Validation
  • Facilities & Operations
  • Stability Scientists
  • Warehouse & Distribution
  • Laboratory Managers
  • Project Managers
  • R & D, Clinical Trials
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Paul Daniel, data integrity webinar

Paul Daniel, Sr. Regulatory Compliance Expert

Paul Daniel has two decades 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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