Name: Data Integrity: FDA, WHO and EMA's Requirements 2021
Start: Thu, 10/28/2021 - 10:00
End: Fri, 10/29/2021 - 04:00
Location: Online

Event Description

Data Integrity: FDA, WHO and EMA's Requirements 2021

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 The FDA Guidance for Industry, "Data Integrity and Compliance with CGMP" was published as a DRAFT guidance in April 2016.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. Other documents include ‘GXP’ Data Integrity Guidance and Definitions” in March 2018 and “Data Integrity and Compliance With Drug CGMP, Questions and Answers in December 2018”. 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 ComplianceOnline 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

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.