Exploring Data Integrity To Include FDA, WHO and EMA’s Latest Guidance for Industry (2018/2019): 2-Day In-Person Seminar

By: Barry A. Friedman, Ph.D, Consultant in Biotechnology, Regulatory Compliance and Aseptic Processing Arena
Location :- Boston, MA | Monday, September 9, 2019 | Tuesday, September 10, 2019

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 The FDA Guidance for Industry, “Data Integrity and Compliance with CGMP” was published as a DRAFT guidance in April 2016.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

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

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
  • Microbiology
  • Document control specialists

Course Outline

Day One (8:30 AM – 4:30 PM)
  • 08.00 AM - 09.00 AM: Registration
  • 09.00 AM: Session Start
    • 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

    Meet Your Instructor

    Barry_A_Friedman_90_112
    Barry A. Friedman, Ph.D
    Consultant in Biotechnology, Regulatory Compliance and Aseptic Processing Arena

    Barry A. Friedman, PhD, is a Consultant in the Biotechnology, Regulatory Compliance and Aseptic Processing Arena. Dr. Friedman possesses over 30 years of industrial managerial experience in various aspects of biopharmaceuticals and medical devices to include regulatory compliance, expert witness testimony, GLP/GMP, quality control, auditing, sterility assurance, microbiological/analytical validations and fermentation technology.

    Prior to becoming an independent consultant, Dr. Friedman was associated with Cambrex Bio Sciences, a contract manufacturer of GMP bulk biopharmaceuticals located in Baltimore, Maryland. As the Director of Quality Control, he managed a multi-shift Department of thirty one individuals involved in client management, the receipt and testing of raw materials, environmental monitoring and microbiology, analytical chemistry and QC compliance for the production of Phase 1, 2, 3 and commercial products manufactured from bacteria, yeast and mammalian cells. In this capacity, Dr Friedman enjoyed many client and regulatory interactions, both domestic and international.

    Prior to 2000, Dr. Friedman was the Laboratory Director for Chesapeake Biological Laboratories, a contract Aseptic Fill n’ Finish manufacturer located in Baltimore, Maryland. In addition to the professional history listed above, other associations have included W.R. Grace, Sigma Chemical Co., Sherwood Medical, Becton Dickinson, American Cyanamid and Union Carbide.

    Dr. Friedman received his B.S. degree in Microbiology from Ohio State University, his M.S. from Michigan State University in Microbial Genetics, and his PhD from Ohio State University in Microbiology.

    Venue

    Location :
    Boston, MA (Venue to be announced shortly)

    September 9-10, 2019
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    $1,499

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    September 9-10, 2019, Boston, MA
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    (Registrations after August 5, 2019 - $1699)

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