COURSE DESCRIPTION

OVERVIEW

In April 2016, the FDA issued its draft “Data Integrity and Compliance with cGMP Guidance for Industry.” This document quickly followed similar documents issued by other global regulatory bodies including the Medicines and Healthcare products Regulatory Agency (MHRA) and World Health Organization (WHO). These documents were issued in response to the increase in data integrity violations observed during inspections. FDA, for one, is taking this issue seriously as it stated in the draft guidance that the rise in data integrity observations “is troubling because ensuring data integrity is an important component of industry’s responsibility to ensure the safety, efficacy, and quality of drugs, and of FDA’s ability to protect the public health.”

The regulatory expectation that data must be reliable and accurate is certainly not new (as mentioned in the predicate rules), but these documents serve to clarify and standardize current thinking. The focus of this training is to review, compare, and contrast currently available draft and final guidance documents in order to understand the various agencies’ current thinking on data integrity and how it impacts the GxP-regulated industry. The outcome will be the delivery of data governance strategies that position organizations for compliance.

LEARNING OBJECTIVES

Attend this interactive 90-minute webinar and you will…

1. Compare and contrast data integrity guidance content
2. Learn what critical elements most deeply affect the GxP community
3. Understand the relationship of guidance documents to predicate rules
4. Application of the predicate rules to paper and electronic data integrity
5. Identify the most common issues observed with electronic data integrity compliance, including example warning letters
6. Understand the role of robust data governance in achieving compliance
7. Develop strategies that increase data integrity compliance