Data Integrity: FDA, WHO and EMA's Requirements
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. Data Integrity that is not reliable hints of a Company being outside of compliance and questions the quality of the product being produced.
Often the initial "hint" of an off-shore 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 issuing 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 two day seminar various examples of Data Integrity issues will be reviewed to include how and where to locate them during audits. In addition, breakout sessions will be held to learn from each other and other teams as they review the same data and compare their findings. Interestingly, conclusions developed by the various teams often differ from each other.
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 the conclusions developed by each team.
The objective of this seminar 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 seminar is designed to assist in assuring that your organization is maintaining itself within cGMP compliance. Case studies to include Warning Letters will be discussed to illustrate the wide array of issues that continue to arise and how to find them within your organization and your vendors before the regulators. This represents a great opportunity for a team from your Corporation to attend and mutually benefit each other.
Upon completing this course participants should:
Assure your understanding of the fundamental causes of Data Integrity issues
Be able to identify the key elements
Understand how the regulations impact Data Integrity issues
Understanding the various inspection approaches to monitor for Data Integrity
Is there a right or wrong way to monitor for Data Integrity
Learn why Data Integrity that is not reliable hints of a Company being outside of compliance and questions the quality of the product being produced.
Understand the consequences of questionable data and how they may lead to seizures, import alerts, etc
Day One (8:30 AM – 5:00 PM)
Registration Process: 8:30 AM – 9:00 AM
Session Start Time: 9:00 AM
Overview of Data Integrity – The issues
Determination of the regulatory requirements to maintain Data Integrity
A Review of the key elements to maintain Data Integrity to include those within In-coming Materials, Manufacturing, Laboratory, Document Control, Stability
Breakout for Case Studies (Manufacturing or Laboratory)
Discussion of Case Studies to include recommendations, e.g., possible modes of detection of Data Integrity
Applying the results of the Case Studies to the manufacturing issues of a non-sterile and aseptic environment
Day Two (8:30 AM – 4:30 PM)
Applying the results of the Case Studies to the laboratory environment
Import Alerts and what warnings they may send to you if your vendor is involved
Why do fraudulent records continue to appear – despite a history of Warning Letters – A look at the most common FDA CDER Observations and their continuing occurrence
The breathe of falsification to include laboratory, stability, microbial and batch testing – where did they go wrong?
Can contracted manufacturing and testing laboratories be used to minimize data falsification?
Case Studies and recent Warning Letters