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Faculty: Dr. Ginette Collazo ‎ ‎‎ ‎ ‎ |‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ Code: FDB3072

  • Date: 5/21/2024 11:00 AM - 5/21/2024 12:30 PM
  • Time zone: Eastern Time (US/Canada) Online Event


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.

Learning Objectives:

  • 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.

Areas Covered in the Session :

  • 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.

Who Should Attend:

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

Course Director: DR. GINETTE COLLAZO


Ginette Collazo, Ph. D. is an Industrial-Organizational Psychologist with 20 years of experience that specializes in Engineering Psychology and Human Reliability, disciplines that study the interaction between human behavior and productivity. She has held positions leading training and human reliability programs in the Pharmaceutical and Medical Device Manufacturing Industry.

Nine years ago, Dr. Collazo established Human Error Solutions (HES), a Florida based boutique consulting firm, where she has been able to position herself as one of the few Human Error Reduction Experts in the world. 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 proven amongst different industries globally. This scientific method has been applied in critical quality situations and workplace accidents.

She is the author of the book Human Error: Root Cause Determination Model, published in 2008. She is also a speaker at significant events like Interphex, FDAnews Annual Conference, Global Conference on Process Safety, International Conference on Applied Human Factors and Ergonomics, and of course, Pharmaceutical Industry Association.