Faculty: Charles H. Paul | Code: FDB3367
Ensuring data integrity in laboratories that follow Good Laboratory Practice (GLP) is essential for producing accurate and reliable results that meet regulatory standards. Data integrity refers to the accuracy, consistency, and reliability of data throughout its lifecycle, from initial collection to storage and reporting. Key to this is following the ALCOA+ principles, which set the framework for trustworthy data: ensuring all data is attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, and available. Adherence to these principles helps laboratories prevent errors, omissions, and potential data manipulation, which can undermine both scientific results and regulatory compliance.
The regulatory environment for data integrity is governed by guidelines from bodies like the FDA, EMA, and WHO, all of which emphasize that integrity is essential for ensuring that data is a true and complete record of the work performed. Challenges to data integrity, such as incomplete documentation, unauthorized data changes, and inadequate training, can compromise the reliability of laboratory results and lead to significant compliance penalties. Implementing data integrity best practices, such as developing robust Standard Operating Procedures (SOPs), using secure Electronic Data Management Systems (EDMS), and performing regular audits, is critical to maintaining GLP standards. By doing so, laboratories can produce high-quality data that is not only compliant but also scientifically credible and reproducible.
WHY YOU SHOULD ATTEND:
This webinar, GLP Data Integrity: Ensuring Accurate, Reliable Results, will provide a thorough overview of data integrity principles essential for Good Laboratory Practice (GLP). Participants will explore the fundamentals of GLP and understand how data integrity directly impacts regulatory compliance, scientific credibility, and overall data quality in laboratory environments. The session will review the ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available), which are fundamental to maintaining trustworthy data, as well as various international guidelines from bodies such as the FDA, EMA, and WHO that outline specific data integrity requirements.
The webinar will also cover common data integrity challenges, such as data entry errors, incomplete records, and insufficient staff training, illustrating these issues with real-world examples where data integrity lapses led to regulatory consequences. Attendees will gain practical strategies to overcome these challenges, including tips for implementing ALCOA+ principles, establishing robust Standard Operating Procedures (SOPs), leveraging Electronic Data Management Systems (EDMS), and conducting regular audits. Through these insights, participants will be equipped with actionable practices to strengthen data integrity, thereby supporting both regulatory compliance and the generation of reliable, high-quality scientific data.
Attending this webinar on GLP Data Integrity: Ensuring Accurate, Reliable Results is essential for anyone working in laboratory environments that need to comply with strict regulatory standards. Participants will gain a practical understanding of the ALCOA+ principles, which are crucial for maintaining data that is accurate, complete, and reliable. The session will provide insights into current regulatory requirements and common data integrity challenges, equipping attendees with actionable strategies to address issues that could compromise data quality or lead to compliance risks. By implementing the best practices discussed, participants will enhance their ability to maintain robust data integrity, supporting both scientific credibility and regulatory compliance in their organizations.
LEARNING OBJECTIVES:
AREAS COVERED:
Overview of GLP and Data Integrity
Regulatory Requirements and Guidelines
Common Data Integrity Challenges
Strategies and Best Practices for Ensuring Data Integrity
WHO SHOULD ATTEND:
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