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

Data integrity is a critical component of compliance and operational success in regulated industries such as pharmaceuticals and medical devices. Ensuring that data remains accurate, complete, and consistent throughout its lifecycle is essential for maintaining trust and meeting regulatory expectations. However, human error poses a significant threat to data integrity, with mistakes in data entry, processing, and analysis leading to costly breaches and compliance risks.

Live Online Training
March 17, Tuesday 10:00 AM PT | 01:00 PM ET (90 Mins)

$189.00
One Dial-in One Attendee
$899.00
Group-Max. 10 Attendees/Location
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Recorded Version Only

(PPT + Recorded Streaming Link)

$249.00
1x Person - Unlimited viewing for 6 Months (For multiple locations contact Customer Care)
rec Recorded Link and Ref. material will be available in My Account Section 48 hrs after completion of Live training

Download File Only

(PPT + Recorded Training File)

$349.00
Downloadable file is for usage in one location only.
(For multiple locations contact Customer Care)
Downloadable link along with the materials will be emailed within 2 business days after completion of Live training
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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
Instructor Profile:
Ginette M Collazo Ginette M Collazo

Organizational Psychologist, Ginette M Collazo Inc

Ginette Collazo, Ph. D. is an Industrial-Organizational Psychologist with more than 20 years of experience specializing in Engineering Psychology and Human Reliability. These disciplines 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.

In 2009, Dr. Collazo established Human Error Solutions (HES), a US-based boutique consulting firm. 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 implemented and proven amongst different industries globally. Furthermore, this scientific method has been applied in critical quality situations and workplace accidents. As a GMP expert also has a Keynote Speaker at significant events around the world.

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.”

Also, she is the host of The Power of Why Podcast. A show about human behavior in the workplace and critical thinking.

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. FDATrainingAlert would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@fdatrainingalert.com call +1-888-771-6965 (Toll Free).

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