Data Integrity - It's Not New and So Much More than Just Computers


Instructor: David Husman
Product ID: 706410
Training Level: Basic to Advanced

  • Duration: 60 Min
This webinar will discuss the recent attention regulators have placed on data integrity and show how the requirements are not new. The sources of data issues go far beyond the laboratory and are not just found in computer/electronic systems.
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Why Should You Attend:

This webinar provides an overview of the regulations, recent regulator citations, an approach to pragmatic compliance and a list of areas to focus on to ensure your organizations have data with integrity.

Data integrity has been in the news – from issuance of new guidance, increases in citations and warning letters to a perceived emphasis on laboratories. Companies have thought – this must be new, it’s only in China and India, well it’s just in the laboratory or it’s just bad actors. This webinar shows how the focus on data integrity really is nothing new, is found all over the world from small pharma to the largest organizations and is so much more than just computer data or laboratory records.

Areas Covered in the Webinar:

  • Background
    • Principles
    • Key Definitions
    • Regulations / Guidance
      • US
      • EU
      • Others
  • Regulatory Enforcement
    • Recent Trends
    • Example Citations
  • Pragmatic Compliance
    • Governance
      • Policy
      • QMS
      • Security Controls
    • Management / Culture
    • Record Management
      • Paper
      • Electronic
    • Equipment Management
  • Specific Areas of Focus
    • Personnel
    • Laboratory
    • Facilities and Utilities
    • Warehouse
    • Production
    • Oversight

Who Will Benefit:

  • Laboratory Personnel
  • Information System Management
  • Quality Assurance Management
  • Regulatory Affairs
  • Senior Management
  • Facility/Engineering

From the following industries:

  • Pharma, Bio-pharma, Medical Device – all aspects from clinical to commercial.

Free Materials:

  • Copy of Data integrity article
  • Husman, David W and Eng, Wanda, “How to Conduct Data Integrity Investigation Interviews”, RF Today, 13 Dec 2017, Regulatory Affairs Professionals Society.
Instructor Profile:
David Husman

David Husman
President and Principal Consultant, David Husman Consulting LLC
  • Over 30 years of diverse international industry experience in Quality Assurance, Quality Control and Regulatory Affairs. Last 18 years as a consultant to biopharma, pharma and device industries.
  • Experience has spanned from R&D to Commercial Manufacture
  • Background includes, but not limited to, parenteral products, human tissue products, blood products, biotech products, solid dosage, vaccines, implantable devices, and in vitro diagnostic products for both human and animal species.
  • Extensive experience in laboratory operations including but not limited to auditing, development of laboratory system procedures, implementation of laboratory at a new site and forensic data integrity investigations.
  • Experience in all parts of the manufacturing operation from warehousing to packaging, from facilities and utilities to laboratories to computer systems, from regulatory to quality control.
  • Expert level in Compliance and Quality System development.
  • Executed numerous Data Integrity assessments and remediation projects worldwide.
  • Ph.D. in Biochemistry, Certified as a GMP expert and in Regulatory Affairs.
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