In 2015 the FDA issued warnings to 10 companies for data integrity violations, the most in the last 10 years. And between Jan 2015 and May 2016, 75% of all FDA warning letters included lapses in data integrity. In response to the growing risk of these problems, in April 2016, the FDA released the draft guidance “Data Integrity and Compliance with CGMP Guidance for Industry” to clarify the role of data integrity in current good manufacturing practice (CGMP) for drugs. With inspectors and auditors putting a priority on the integrity of your data, do you know if your laboratory informatics systems and procedures are ready to comply? Are you addressing integrity issues on a case-by-case basis or are you assessing your overall CSV program? Find out where you need to focus your efforts to best ensure the integrity of your data.
In one hour, you will see some real world examples of where the biggest gaps and risks are with respect to data integrity and recommended ways to mitigate them. You will learn an approach to complying with data integrity requirements based on Delivering Excellence within your company. Join us as we discuss how the new draft guidance applies to your labs and your data and discover ways to protect your GxP data.
- Understand the key points of the Guidance
- Learn how the Guidance applies to your laboratory informatics systems
- Discover the common pitfalls of data integrity
- See how you can leverage experience and industry knowledge to be compliant