Investigating FDA Data Integrity Regulatory Issues in a Manufacturing/Laboratory Environment
: 15 Oct 2019
Sector: Clinical, Cosmetic/Personal Care, Pharmaceutical, Veterinary, Water
Type: Training, Webinar
Data Integrity has become a non-compliance area often observed by the FDA and reported within Form FDA 483s and Warning Letters. While various governments have observed this on a world-wide basis, the FDA has been reporting its occurrence off-shore with a greater frequency than usually observed within the United States. A lack of Data Integrity hints of a Company being outside of compliance, e.g, product being adulterated, and questions the quality of the product being produced.
Several documents have recently been published by the FDA, MHRA and WHO. The FDA Guidance for Industry, “Data Integrity and Compliance with CGMP” was published as a DRAFT guidance in April 2016. This Guidance was issued to clarify the role of Data Integrity in CGMP for drugs. In March 2015, the MHRA published a Guidance entitled “MHRA GMP Data Integrity Definitions and Guidance for Industry” which mirrored the 2016 FDA document. Various source documents to include 21 CFR 210/211, FDA Guidances for Industry, Standard Industry Practices and other International sources will be used to support this live presentation.
The objective of this live, interactive webinar is to explore and define the necessary elements in the development and implementation of a Data Integrity program and how to maintain Quality Systems that minimize these issues. This webinar is designed to assist in assuring that your organization is maintaining itself within cGMP compliance and will focus upon Information Technology, Manufacturing and Laboratory interrelationships.
- assure your understanding of the fundamental causes of data integrity issues
- be able to identify these key root causes and why “retraining’ is no longer a solution
- understand how cgmp regulations impact data integrity issues
- understanding the various inspection approaches to monitor for data integrity
- learn how to determine the regulatory requirements required to assure data integrity
- understand the consequences of questionable data and how they may lead to seizures, import alerts, etc...
- learn from examples of warning letters which emphasize manufacturing and laboratory activities