GMP Data Integrity Best Practices and Regulatory Expectations for the Pharmaceutical Industry
: 25 Jul 2019
Sector: Clinical, Pharmaceutical, Veterinary
Type: Training, Webinar, Seminar
In 2015, MHRA issued a comprehensive guidance on the subject of data integrity followed by another in 2016 to broaden the topic. In 2018, MHRA finally issued the full complete guidance. In April 2016 the FDA also issued their own a guidance to help us. In addition, the WHO and PIC/S have also issued guidances in 2016.
This live interactive webinar we will examine the issues surrounding data integrity lapses. We will examine the types, how to detect them, how to determine the root causes of these failures. Intentional and unintentional failures point to different root causes which then lead to different solutions. We will examine how the Europeans have taken the issue seriously and are meeting the challenge face on by reviewing the new MHRA GMP Data Integrity Definitions and Guidance released in January 2015.
- MHRA GMP data integrity definitions and guidances are explained.
- FDA data integrity guidance definitions and principles are described.
- You will learn how to examine your supply chain and development programs with the use of Quality Risk Management to identify where risk of data integrity lapses are present.
- You will learn the tell-tale signs that you have data integrity problems.
- You will learn how to tell the difference between intentional and unintentional failures of data integrity.
- You will learn how to develop a remediation plan to decrease risk to an acceptable level in your operations.
- You will learn how to be proactive in areas the FDA focused on and by learning from the Europeans and being ahead of the game.
- Understand how regulatory agencies detect data integrity problems.
- Understand how MHRA vs the FDA are tackling the issues.
- How to integrate the FDA and MHRA approaches into your data integrity program.