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Data Integrity And Human Error

Data integrity refers to the accuracy, completeness, and consistency of data over its entire lifecycle. Data integrity is crucial for any organization as it ensures that the data they rely on to make decisions is trustworthy and reliable. Human error can have a significant impact on data integrity. For example, data entry errors, such as mistyping a number or letter, can cause data to be inaccurate. Additionally, mistakes made during data processing or analysis, such as applying the wrong formula or method, can lead to incorrect results. To ensure data integrity, it is important to implement controls that minimize the risk of human error.

Webinar Nov 20 2025, Thursday 01:00 PM EDT 90 Minutes Intermediate Level Code: GRC0000136
Speaker
By GINETTE COLLAZO In Quality And Safety , All FDA Regulated Industry
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  • Importance of data integrity
     -  Overview of data integrity principles
     -  Goals and objectives of the training session
  • Data Integrity and human error
     - Error Types
     -  Measurement
     -  Strategies 
  • Overview of ALCOA principles
     -  Definition of ALCOA
     -  Explanation of each ALCOA principles
     -   Importance of ALCOA in maintaining data integrity
  • Common threats to data integrity
     -  Human error
     -  Malicious intent
     -  Technical failures
     -  Consequences of data integrity breaches
  • Techniques to ensure data integrity
     -  Data backups
     -  Data validation
     -  Audit trails
     -  Access controls
     -  Encryption
  • Implementation of ALCOA principles 
  • Strategies for incorporating ALCOA into data collection and management processes.

  • To provide an understanding of the importance of data integrity in regulated industries, such as pharmaceuticals and medical devices.
  • To introduce the ALCOA principles as a framework for maintaining data integrity.
  • To identify common threats to data integrity and the consequences of data integrity breaches.
  • To teach techniques for ensuring data integrity, including data backups, data validation, audit trails, access controls, and encryption.
  • To provide strategies for implementing ALCOA principles and case studies of successful implementation.
  • To review relevant regulations and standards that govern data integrity in different industries, and best practices for maintaining data integrity in practice.
  • To share real-world examples of data integrity failures and their consequences, and the importance of adhering to data integrity principles to avoid such failures.
  • To equip participants with the tools and knowledge necessary to maintain data integrity in their own organizations.

  • Training managers and coordinators
  • Manufacturing
  • Plant engineering
  • QA/QC staff
  • Process excellence/improvement professionals
  • Industrial/process engineers
  • Compliance officers
  • Regulatory/legislative affairs professionals
  • General/corporate counsel
  • Executive management

GINETTE COLLAZO
GINETTE COLLAZO
20 Years
Ginette Collazo, Ph. D. is an Industrial-Organizational Psychologist with over 20 years of experience specializing in Engineering Psychology and Human Reliability. She has held positions leading Training and Human Reliability programs in the Pharmaceutical and Medical Device Manufacturing Industry. In 2009, Dr. Collazo established Human Error Solutions (HES), a training and consulting firm, and she has positioned herself as one of the few Human Error Reduction Experts worldwide. HES, led by Dr. Collazo, developed a unique methodology for human error investigations, cause determination, CA-PA development, and effectiveness that has been implemented and tested globally in different industries. Furthermore, this scientific method has been applied in critical quality situations and workplace accidents. As a GMP expert, she has also been a Keynote Speaker at significant events worldwide. Ginette Collazo, Ph. D., is the author of several books, “Human Error: Root Cause Determination Model” and “Mission Matters: World Leading Entrepreneurs Reveal their Top Tips to Success.” In 2023, Human Error Solutions was named a top-ten industrial service provider by Manufacturing Outlook magazine and featured on ABC, Fox, NBC, and CBS news. She hosts The Power of Why Podcast—a show about human behavior in the workplace and critical thinking.

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