Thursday March 28, 2019
12:00 pm – 1:30 pm EDT
Instructor: Barry A. Friedman, Ph.D.
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.
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 The FDA Guidance for Industry, “Data Integrity and Compliance with CGMP” was published as a DRAFT guidance in April 2016.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 December 2018 the FINAL guidance was issued as “Data Integrity and Compliance with Drug CGMP – Questions and Answers”. In March 2015, the MHRA published a Guidance entitled “MHRA GMP Data Integrity Definitions and Guidance for Industry” which mirrored the 2016 FDA document. Most recently, March 2018, the MHRA published “GXP” Data integrity Guidance and Definitions. 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 during this webinar.
The objective of this live, interactive EEC 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. This webinar represents a great opportunity for a team from your Corporation to attend and mutually benefit each other.
Learning objectives include:
- 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
Those who should attend include:
- Quality Assurance
- Quality Control
- Manufacturing
- Validation
- Engineering
Fee:
$385 for one person
$700 2-5 people
$999 6-10 people
Questions? support@eccwebinars.com
ECC-098