San Francisco, California
London, United Kingdom
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
Who Will Benefit:
Those that will benefit from this program include anyone involved in the incoming materials, manufacturing, laboratory, and packaging process within a non-sterile/aseptic pharmaceutical environment.
- Quality professionals
- Regulatory professionals
- Compliance professionals
- Manufacturing engineers
- Quality engineers
- Quality auditors
- Quality Control
- Document control specialists
Note: Use coupon code < NB5SQH8N > and get 10% off on registration.
When & Where
Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.
Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.
Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.
Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.