Investigating FDA Data Integrity Regulatory Issues in a Manufacturing/Laboratory Environment, How cGMP Regulations Impact Data Integrity Issues and Key Elements in the Development & Implementation of a Data Integrity Program

Live, Interactive Training Webinar

Date: Thursday October 25, 2018 - Time: 9:30 - 11:30 AM
Instructor: Barry A.Friedman Ph.D. Biography>>>

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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, e.g, product being adulterated, 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 interactive webinar various examples of Data Integrity issues will be reviewed to include how and where to locate them during audits.

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 The FDA Guidance for Industry, “Data Integrity and Compliance with CGMP” was published as a DRAFT guidance in April 2016.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 this PowerPoint presentation.

The objective of this live, interactive 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 and will focus upon Information Technology, Manufacturing and Laboratory interrelationships. This webinar represents a great opportunity for a team from your Corporation to attend and mutually benefit each other.

Learning Benefits:
--Assure your understanding of the fundamental causes of Data Integrity issues
-Be able to identify these key root causes and why “retraining’ is no longer a solutions
-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...
-Learn from examples of Warning Letters which emphasize Manufacturing and Laboratory activities

Webinar outline and time breakdown:

Time*
09:15 AM Log In Period
09:30 AM Introduction
09:40 AM Definitions,
Review of the Regulations,
Fundamental causes of Data Integrity issues,
Understanding how GMP issues impact Data Integrity,
10:30 AM Break
10:40 AM Learn of the common CFR (211/212) regulations that impact Data Integrity,
Learn about examples of Warning Letters from manufacturing/laboratory issues,
11:30 AM Live Questions & Discussion

*Please note all times are Eastern Time (New York Time)

This live training webinar includes the following for each registered attendee:

  • A copy of the presentation slides
  • A certificate of training for attendee records

Who should attend:
The following individuals or disciplines will benefit from attending this Webinar:

  • Quality Assurance personnel
  • Quality Control personnel
  • Research & Development
  • Regulatory Affairs Professionals
  • Information Technology personnel
  • Microbiology Professionals

Registration Form ►


Instructor: Barry A. Friedman Ph.D.

Barry A. Friedman, Ph.D., is a Senior Consultant in the Biotechnology, Regulatory Compliance and Aseptic Processing arena. Dr. Friedman is a frequent seminar speaker in the GMP areas of internal auditing, aseptic processing of sterile drug products, USP microbiology, validations and the requirements for the manufacture of Phase 1, 2 and 3 clinical trial materials. He has recently given presentations for the FDA, PDA, PTi. He is a member of AAMI, ASM, PDA and RAPS. He served as a Captain in the Medical Service Corps, U.S. Army and is the past President of the Capital Area Chapter, PDA... Full Bio>>>

 

 

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