Training Course Syllabus:

Exploring Data Integrity To Include FDA, WHO and EMA's Latest Guidance for Industry

Course Description:

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 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.

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 The FDA Guidance for Industry, "Data Integrity and Compliance with CGMP" was published as a DRAFT guidance in April 2016.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 the conclusions developed by each team during this two day seminar.

The objective of this two day Compliance On-Line 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 find them for you. This seminar represents a great opportunity for a team from your Corporation to attend and mutually benefit each other.

Learning Objectives:

Upon completing this course participants should:

Assure your understanding of the fundamental causes of Data Integrity issues
Be able to identify these key elements
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

Course Outline:

Day One (8:30 AM – 4:30 PM)

Registration Process: 8:30 AM – 9:00 AM
Session Start Time: 9:00 AM

Overview of Data Integrity – The issues
Background
Purpose/Objective
Definitions
Key definitions within the subject of Data Integrity
Data Integrity
Metadata
Audit Trail
Systems
Determination of the Key Regulatory Requirements to maintain Data Integrity
GMP requirements of Data Integrity
21 CFR 210, 211, and 212 – an explanation of the most common CFR sections
The Most Prevalent 2015 Observations Associated with Data Integrity
A Review of Nineteen Observations
Why do they Repeat Year after Year
A Summary of Data Integrity Issues within:
In-coming Materials
Manufacturing
Laboratory
Training
Finished Products
Documentation
Product Release

Day Two (8:30 AM – 4:30 PM)

Key Issues Associated with Data Integrity to include:
Exclusion of Data from Decision Making
Validation of Workflow
Restriction to Computer System Access
Data Integrity Remediation
And Many more
Breakout for Case Studies
Discussion of Case Studies to include recommendations
The breathe of falsification to include laboratory, stability, microbial and batch testing – where did they go wrong?
Hemofarm - Serbia – Microbiological Issues
Unimark – Basic issues with Data Integrity
Megafine Pharma Limited – Liquid Chromatography
Micro Labs LTD – Laboratory Records
Why Import Alerts may share Early Warning Issues
Why do fraudulent records continue to appear – despite a history of Warning Letters
Avoiding Responsibility through Contract Manufacturing and Testing Facilities – Does this work?
Case Studies and recent Warning Letters

Seminar Summary:

Data Integrity has become a non-compliance area often observed by the FDA and reported within Form FDA 483s and Warning Letters. (see full course description)

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