Data Integrity & Human Error: Ensuring Compliance and Accuracy in Life Sciences
Understand, Identify, and Eliminate Human Errors To Protect Data Integrity!
Instructor :
Ginette Collazo
Webinar ID:
13548
Date: APR 23, 2025 (WED)
Start Time: 10 AM PT - 11:30 AM PT
Duration: 90 Mins.
What you will learn
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- Understand The Core Principles Of Data Integrity
- Identify Common Human Errors And Their Impact
- Apply ALCOA+ Principles To Maintain Data Accuracy
- Recognize Threats To Data Integrity And Compliance Risks
- Implement Effective Controls To Prevent Data Breaches
- Utilize Audit Trails, Validation, And Access Controls
- Develop Strategies For ….
-
- Understand The Core Principles Of Data Integrity
- Identify Common Human Errors And Their Impact
- Apply ALCOA+ Principles To Maintain Data Accuracy
- Recognize Threats To Data Integrity And Compliance Risks
- Implement Effective Controls To Prevent Data Breaches
- Utilize Audit Trails, Validation, And Access Controls
- Develop Strategies For Ensuring Regulatory Compliance
- Learn From Real-World Case Studies And Best Practices
Course Description
In the life sciences industry, ensuring data integrity is not just a best practice—it’s a regulatory requirement.
Inaccurate, incomplete, or inconsistent data can lead to compliance violations, product recalls, and compromised patient safety.
Human error remains one of the leading causes of data integrity failures, often resulting from data entry mistakes, incorrect calculations, or improper handling of critical information.
This comprehensive training provides a deep dive into the fundamentals of data integrity and the role of human error in data discrepancies.
Participants will gain a thorough understanding of how data should be recorded, processed, and maintained to comply with global regulatory standards, including FDA, EMA, and GxP guidelines.
Key Learning Outcomes:
-
- Understand Data Integrity Principles
-
- Learn the core aspects of accuracy, completeness, and consistency in data handling.
-
- Understand Data Integrity Principles
-
- Identify Common Human Errors
-
- Recognize how mistakes in data entry, processing, and analysis impact compliance.
-
- Identify Common Human Errors
-
- Implement Effective Controls
-
- Discover proven strategies and best practices to prevent human errors and enhance data integrity.
-
- Implement Effective Controls
-
- Comply with Regulatory Expectations
-
- Gain insights into global compliance requirements and industry best practices.
-
- Comply with Regulatory Expectations
-
- Develop a Culture of Accountability
-
- Foster a data-driven mindset within your organization to reduce errors and improve reliability.
-
- Develop a Culture of Accountability
By the end of this training, attendees will be equipped with practical knowledge and actionable strategies to mitigate human errors and safeguard data integrity in their organizations.
Enroll Now!
In the life sciences industry, ensuring data integrity is not just a best practice—it’s a regulatory requirement.
Inaccurate, incomplete, or inconsistent data can lead to compliance violations, product recalls, and compromised patient safety.
Human error remains one of the leading causes of data integrity failures, often resulting from data entry mistakes, incorrect calculations, or improper handling of critical information.
This comprehensive training provides a deep dive into the fundamentals of data integrity and the role of human error in data discrepancies.
Participants will gain a thorough understanding of how data should be recorded, processed, and maintained to comply with global regulatory standards, including FDA, EMA, and GxP guidelines.
Key Learning Outcomes:
-
- Understand Data Integrity Principles
-
- Learn the core aspects of accuracy, completeness, and consistency in data handling.
-
- Understand Data Integrity Principles
-
- Identify Common Human Errors
-
- Recognize how mistakes in data entry, processing, and analysis impact compliance.
-
- Identify Common Human Errors
-
- Implement Effective Controls
-
- Discover proven strategies and best practices to prevent human errors and enhance data integrity.
-
- Implement Effective Controls
-
- Comply with Regulatory Expectations
-
- Gain insights into global compliance requirements and industry best practices.
-
- Comply with Regulatory Expectations
-
- Develop a Culture of Accountability
-
- Foster a data-driven mindset within your organization to reduce errors and improve reliability.
-
- Develop a Culture of Accountability
By the end of this training, attendees will be equipped with practical knowledge and actionable strategies to mitigate human errors and safeguard data integrity in their organizations.
Enroll Now!
Why you should attend
In today’s highly regulated life sciences industry, ensuring data integrity is more than a best practice—it’s a critical compliance requirement.
Organizations face increasing scrutiny from regulatory agencies, and even minor data integrity breaches can lead to serious financial, operational, and reputational risks.
This training is designed to provide practical, real-world solutions for preventing human errors and maintaining compliance with global regulations. Attendees will:
-
- Gain a clear understanding of why data integrity is essential in pharmaceuticals, medical devices, and other regulated sectors.
- Learn how to apply ALCOA+ principles to ensure data is accurate, complete, and secure throughout its lifecycle.
- Identify the most common threats to data integrity, their consequences, and strategies to mitigate them.
- Explore case studies of data integrity failures to understand the impact of non-compliance and how to avoid similar mistakes.
- Discover best practices for implementing data validation, audit trails, access controls, and encryption to strengthen compliance.
With expert-led insights, real-world examples, and actionable strategies, this course will empower you to protect your organization from data integrity risks and ensure compliance.
Join Now!
In today’s highly regulated life sciences industry, ensuring data integrity is more than a best practice—it’s a critical compliance requirement.
Organizations face increasing scrutiny from regulatory agencies, and even minor data integrity breaches can lead to serious financial, operational, and reputational risks.
This training is designed to provide practical, real-world solutions for preventing human errors and maintaining compliance with global regulations. Attendees will:
-
- Gain a clear understanding of why data integrity is essential in pharmaceuticals, medical devices, and other regulated sectors.
- Learn how to apply ALCOA+ principles to ensure data is accurate, complete, and secure throughout its lifecycle.
- Identify the most common threats to data integrity, their consequences, and strategies to mitigate them.
- Explore case studies of data integrity failures to understand the impact of non-compliance and how to avoid similar mistakes.
- Discover best practices for implementing data validation, audit trails, access controls, and encryption to strengthen compliance.
With expert-led insights, real-world examples, and actionable strategies, this course will empower you to protect your organization from data integrity risks and ensure compliance.
Join Now!
Areas Covered
1. Introduction to Data Integrity
-
- Overview of data integrity principles
- Goals and objectives of the training session
2. Understanding Data Integrity & Human Error
-
- Types of human errors affecting data integrity
- Measuring error impact and identifying root causes
- Strategies to mitigate human error in data handling
3. Overview of ALCOA Principles
-
- Definition of ALCOA and its significance
- Detailed explanation of each ALCOA principle (Attributable, Legible, Contemporaneous, Original, Accurate)
- Role of ALCOA+ (Complete, Consistent, Enduring, Available) in ensuring compliance
4. Common Threats to Data Integrity
-
- Human error and its role in data inconsistencies
- Malicious intent: Identifying and preventing data tampering
- Technical failures: Recognizing risks in automated and digital systems
- Consequences of data integrity breaches and regulatory implications
5. Techniques to Ensure Data Integrity
-
- Data backups and disaster recovery planning
- Data validation methods for accuracy and consistency
- Audit trails for tracking modifications and ensuring accountability
- Access controls & encryption to safeguard sensitive information
6. Implementation of ALCOA Principles
-
- Best practices for embedding ALCOA principles in daily operations
- Strategies for integrating ALCOA into data collection and management
BONUS:
-
- PDF copy of the presentation handout for your future reference.
- Soft copy of the certificate of completion on request.
- Q&A Session with the Presenter: Get your pressing questions answered verbally, via chat or email
1. Introduction to Data Integrity
-
- Overview of data integrity principles
- Goals and objectives of the training session
2. Understanding Data Integrity & Human Error
-
- Types of human errors affecting data integrity
- Measuring error impact and identifying root causes
- Strategies to mitigate human error in data handling
3. Overview of ALCOA Principles
-
- Definition of ALCOA and its significance
- Detailed explanation of each ALCOA principle (Attributable, Legible, Contemporaneous, Original, Accurate)
- Role of ALCOA+ (Complete, Consistent, Enduring, Available) in ensuring compliance
4. Common Threats to Data Integrity
-
- Human error and its role in data inconsistencies
- Malicious intent: Identifying and preventing data tampering
- Technical failures: Recognizing risks in automated and digital systems
- Consequences of data integrity breaches and regulatory implications
5. Techniques to Ensure Data Integrity
-
- Data backups and disaster recovery planning
- Data validation methods for accuracy and consistency
- Audit trails for tracking modifications and ensuring accountability
- Access controls & encryption to safeguard sensitive information
6. Implementation of ALCOA Principles
-
- Best practices for embedding ALCOA principles in daily operations
- Strategies for integrating ALCOA into data collection and management
BONUS:
-
- PDF copy of the presentation handout for your future reference.
- Soft copy of the certificate of completion on request.
- Q&A Session with the Presenter: Get your pressing questions answered verbally, via chat or email
Who is this course for
Everybody Benefits from Watching This. Even Better When Done as a Group!
-
- Quality Assurance And Compliance Professionals
- Regulatory Affairs And Compliance Managers
- Data Integrity And Validation Specialists
- Pharmaceutical And Medical Device Professionals
- Clinical Research And Laboratory Personnel
- IT And Data Management Teams
- Manufacturing And Production Supervisors
- Risk Management And Auditing Professionals
Everybody Benefits from Watching This. Even Better When Done as a Group!
-
- Quality Assurance And Compliance Professionals
- Regulatory Affairs And Compliance Managers
- Data Integrity And Validation Specialists
- Pharmaceutical And Medical Device Professionals
- Clinical Research And Laboratory Personnel
- IT And Data Management Teams
- Manufacturing And Production Supervisors
- Risk Management And Auditing Professionals
Instructor Profile
Ginette Collazo, Ph.D., is an Industrial-Organizational Psychologist with 20 years of experience specializing in Engineering Psychology and Human Reliability—disciplines that study the interaction between human behavior and productivity. She has held leadership positions in training and human reliability programs in the pharmaceutical and medical device manufacturing industries.
Nine years ago, Dr. Collazo founded Human Error Solutions (HES), a Florida-based boutique consulting firm, where she has positioned herself as one of the few Human Error Reduction Experts in the world. Under Dr. Collazo’s leadership, HES developed a unique methodology for human error investigations, cause determination, CAPA development, and effectiveness, which has been implemented and proven across various 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. Dr. Collazo is also a speaker at prominent events such as Interphex, FDAnews Annual Conference, Global Conference on Process Safety, International Conference on Applied Human Factors and Ergonomics, and the Pharmaceutical Industry Association
