Pharmaceutical Data Integrity Online Training

Data Integrity Introduction (10 minutes)

In this complimentary introduction to NSF's eLearning modules on data integrity, our expert, Rachel Carmichael, takes a high-level look at why data integrity matters.

Key Learning Objectives:

• A clear understanding of what data integrity is/is not
• Background to the topic, including common issues
• Basics of ALCOA

Data Integrity: Overview and Documentation Completion, Review and Approval

Problems with data integrity continue to lead to vigorous regulatory actions. Such issues can be prevented with a thorough knowledge and understanding of regulators’ requirements. This eLearning course is aimed at anyone working in the pharmaceutical industry. It is designed to provide an overview of data integrity, what needs to be considered during documentation completion, review and approval, and how to keep your data complete, consistent and accurate throughout the data lifecycle.

Key Learning Objectives:

• Key data integrity terms and definitions
• Good documentation practice concerning data integrity
• Good documentation design to allow good documentation completion and the five main types of errors within records
• Review and approval of documents, including making corrections
• Audit trail review
• Document right-first-time metrics

Data Integrity: Beyond the Basics

Give your management and quality unit the confidence to get involved with a deeper understanding of data integrity. This module builds on the key messages of module 1 and goes beyond the basics to examine more specialized aspects of this topic that have a broad impact. Consolidating the knowledge and 11-years of experience from a former MHRA inspector, the course is designed to highlight the known weaknesses in company systems.

The course consists of four parts:

• Part 1 explores self-inspection and internal auditing.
• Part 2 is a short module highlighting the benefits of Gemba Walks from a data integrity point of view. The course examines how this approach differs from self-inspection and can increase overall understanding and relationship building.
• Part 3 considers the deficiencies experienced in different aspects of the operation.
• Part 4 focuses on computers systems.

Data Integrity: Management Requirements

The third module builds on your essential knowledge to understand what senior management should ensure is in place, in use and effective.

Key Learning Objectives:

Attendees will gain an understanding of regulators’ expectations of company leadership addressing:

• Culture
• Risk-based approach
• Data governance linked to technical and organizational controls
• Organizational controls (procedures and training)

Book the entire series as a bundle to benefit from costs saving.

We also offer a customizable instructor-led training course that can be delivered virtually or in-person to you and your team at a time that suits you best. Contact us for more details.