Investigating FDA Data Integrity Regulatory Issues in a Manufacturing/Laboratory Environment
: 23 Jul 2019
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 it's occurence 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.
Often the initial "hint" of an FDA problem occurs within FDA "circles" when one first observes an "Import Alert". These import alerts don't offer much information other than the country, the company and the product. However this becomes a tell-tale signal that a warning letter will most likely be issued within three to four months.
Data integrity issues may represent very simplistic issues that any auditor may readily observe to those that are so complex that only someone very skilled in the art of auditing can readily find them. During this interactive webinar various examples of data integrity issues will be reviewed to include how and where to locate them during audits.
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 compliance issues.