Workshop Overview

Data integrity is a cornerstone of quality assurance in any regulated industry. Reliable data is crucial for making informed decisions, ensuring compliance, and protecting patient safety. Unmanaged and inaccurate data can lead to severe consequences, including compromised product quality, regulatory non-compliance, and increased risks to patients. The FDA and other regulatory bodies have stringent expectations for data integrity, requiring firms to implement robust strategies to manage data integrity risks effectively.

This webinar provides a comprehensive understanding of data integrity principles, and preventing data integrity issues. Participants will learn about regulatory expectations, the key principles of ALCOA+, and review FDA warning letters. This webinar will help attendees develop a compliant data integrity program that safeguards their organization’s quality and compliance efforts.

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Who Should Attend

This workshop is designed for Quality Assurance professionals, Regulatory Affairs specialists, compliance officers, and anyone involved in data management within the pharmaceutical, food, or cannabis industries. It is particularly beneficial for those responsible for ensuring data integrity, managing data systems, and addressing regulatory requirements related to data integrity.

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Workshop Outline

This workshop covers the following topics:

• Understanding the definition and importance of data integrity
• Reviewing regulatory expectations and frameworks for data integrity
• Identifying common root causes of data integrity failures
• Learning how to comply with FDA data integrity requirements
• Analyzing FDA warning letters and 483s related to data integrity

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Learning Outcomes

Comprehensive Understanding of Data Integrity
Develop a deep understanding of data integrity principles, their importance, and regulatory expectations.

Evaluating Compliance and Identifying Failures
Learn to evaluate data integrity compliance effectively and identify potential failures within your systems.

Designing Robust Data Integrity Systems
Gain practical knowledge on how to design systems that incorporate data integrity by design, preventing issues before they arise.

All participants will receive a certificate of attendance upon completion of the workshop.

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Note: Registration closes one week prior to the start of workshop. Workshop registration is intended for individual use only. Each registration grants access to one participant. If you plan to attend as a group or company team, please ensure that each participant is registered separately. Group rates and corporate packages are available—contact us for details.

Refunds are only available if cancellation is requested at least 48 hours before the workshop. No refunds will be issued for late cancellations.