Ensuring Data Integrity and Minimizing Human Error: Practical Strategies and Tools for Success

This webinar provides a comprehensive exploration of data integrity principles, focusing on the ALCOA (Attributable Legible Contemporaneous Original Accurate) framework as a foundation for ensuring data reliability. Participants will learn to identify and address threats to data integrity, implement effective controls, and integrate strategies like data validation, audit trails, and encryption. Real-world case studies will illustrate the consequences of data integrity failures and offer actionable solutions for safeguarding critical information.

Why Should You Attend:

Data integrity is the foundation of trust and compliance in regulated industries like pharmaceuticals, medical devices, and biotechnology. It ensures that the data used to make critical decisions is accurate, complete, and consistent throughout its lifecycle. However, human error remains a significant threat to data integrity, from data entry mistakes to missteps during analysis or processing.

This webinar equips participants with the tools and knowledge needed to protect data integrity in their organizations. Attendees will learn to identify common threats, understand the ALCOA principles for maintaining data reliability, and implement practical strategies like data validation, audit trails, and encryption. Real-world examples of data integrity failures and their consequences will highlight the importance of adherence to data integrity principles.

Learning Objectives:

• Understand the importance of data integrity in regulated industries.
• Learn the ALCOA principles and their role in maintaining data reliability.
• Identify threats to data integrity, including human error, malicious intent, and technical failures.
• Discover techniques to safeguard data, such as validation, audit trails, and encryption.
• Gain strategies for integrating ALCOA principles into data management processes.
• Review real-world case studies of data integrity failures and lessons learned.
• Explore best practices for compliance with relevant regulations and standards.

Areas Covered in the Webinar:

• Principles and importance of data integrity.
• Overview and application of ALCOA principles.
• Identifying error types and common threats to data integrity.
• Techniques for ensuring data reliability
• Backups, validation, audit trails, access controls, and encryption.
• Strategies for incorporating ALCOA into processes.
• Consequences of data breaches and how to prevent them.
• Relevant regulations and compliance best practices.
• Real-world case studies and actionable recommendations.

Who Will Benefit:

This webinar is ideal for professionals in GMP-regulated and compliance-focused industries, including:

• Training managers and coordinators
• Manufacturing Teams
• Plant Engineers
• QA/QC staff
• Process Improvement Specialists
• Industrial and Process Engineers
• Compliance officers
• Regulatory and Legislative Affairs Professionals
• General/Corporate Counsel
• Executive Management

Ginette M Collazo
Organizational Psychologist, Ginette M Collazo Inc

Ginette Collazo, Ph. D. is an Industrial-Organizational Psychologist with over 20 years of experience specializing in Human Reliability and Engineering Psychology. She has led training and reliability programs across regulated industries, including pharmaceuticals and medical devices.

As the founder of Human Error Solutions (HES), Dr. Collazo has developed proprietary methodologies for error investigations, root cause analysis, and CAPA implementation. Her work has been applied globally, ensuring quality and operational excellence.

Dr. Collazo is the author of Human Error: Root Cause Determination Model and a sought-after speaker at major conferences. She also hosts The Power of Why Podcast, focusing on workplace behavior and critical thinking.

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