Data Integrity: FDA/EMA/TGA Requirements and Implementation: 2-Day In-Person Seminar by Ex-FDA Director

By: David L. Chesney, Principal and General Manager, DL Chesney Consulting, LLC (Former FDA Director)
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Course Description:

The integrity of data generated in support of marketing authorizations and in GMP, GCP and GLP regulated activities is foundational to sound decision making and regulatory compliance. Data integrity lapses are among the most serious concerns that pharmaceutical regulatory authorities have. Enforcement penalties can be severe from a business standpoint, and in extreme cases can even impact individuals who are held responsible for the occurrence of data integrity problems. In recent months the topic of data integrity has been in the forefront of concern among worldwide pharmaceutical regulatory agencies. The FDA, EMA, TGA and others have published guidelines setting forth their requirements and expectations for the maintenance of data integrity, as has at least one leading industry organization (PDA).

The use of computer systems in virtually every aspect of data acquisition, storage, and analysis can help preserve data integrity and reduce or eliminate many errors, but the same technology can also create unique problems that must be prevented and managed.

In this two day workshop conference you will learn the meaning of “data integrity”; be exposed to some of the history that influences current regulatory requirements and expectations; see a comparison of the current guidance from leading regulatory agencies including the FDA, EMA, TGA and key industry associations such as the Parenteral Drug Association; see a recap of the enforcement options available to the FDA, including imposition of the Application Integrity Policy (also known as the “Fraud Policy”); discuss and learn from selected current real-life case histories; and hear advice for how to prevent, detect and react to data integrity problems so as to minimize business and regulatory risk.

Learning Objectives:

Upon completing this course participants should:

  • Understand the meaning of the term “data integrity” and the importance of the acronym “A.L.C.O.A.” to regulatory agencies
  • Understand the difference between innocent lapses and deliberate wrongful conduct
  • Be aware of some of the key historical events that form the basis for regulators’ concerns about data integrity
  • Understand some of the common motivations for deliberate wrongful conduct that results in data falsification
  • Understand the impact of the use of computer systems on the maintenance of data integrity, and what types of system controls are mandated by various agencies around the world
  • Be aware of the possible business and regulatory consequences of noncompliance
  • Understand the important steps to take to prevent, detect and react to data integrity problems

Who will Benefit:

This course is designed for people who generate, review and archive data in support of marketing authorization applications to health regulatory agencies such as the FDA, EMA and TGA, and those who generate, review and archive GMP, GCP and GLP data in manufacturing, clinical trials and pre-clinical testing laboratories. The following personnel will benefit from the course:

  • Senior Quality and Regulatory Affairs managers
  • Clinical and Manufacturing Quality professionals
  • Regulatory Affairs professionals
  • Compliance professionals
  • In House Legal Counsel
  • Production supervisors
  • Manufacturing personnel
  • Production personnel
  • Laboratory Managers
  • Clinical Operations Personnel
  • Drug Safety (Pharmacovigilance) Personnel
  • R&D and Quality Control Scientists
  • Quality auditors

Course Outline

Day One (8:30 AM – 4:30 PM)
  • 08.30 AM - 09.00 AM: Registration
  • 09.00 AM: Session Start
  • Introductions
    • Instructor
    • Participants
    • Determination of participant’s desires and expectations for the session
  • Introduction to data integrity
    • Defining data integrity
    • “ALCOA” acronym meaning
    • Criticality of data integrity to “GXP”-governed activities
    • “Fraud” versus innocent conduct that can lead to data integrity lapses
    • Examples from other industries (automobiles, finance, etc.)
  • Historical Perspectives
    • The American “Generic Drug Scandal” of the late 1980s- early 90s and its consequences
    • Expansion of computer system use in GXP operations and its impact
    • Emergence of current worldwide concern among regulators
  • Motivators behind deliberate wrongful conduct
    • “Achieve gain”
    • “Avoid pain”
    • Managing to avoid the “Law of Unintended Consequences”
  • Computer system issues
    • Audit trails
    • Changes to data
    • Metadata implications for data integrity
    • Computer System Controls required by the US and EMA
  • FDA Case studies of data integrity issues
    • GMP
    • GCP
    • GLP
Day Two (8:30 AM – 4:30 PM)
  • Welcome and time for questions from day one
  • Comparison of current data integrity guidance documents from regulators and industry sources
    • FDA
    • EMA
    • PDA Code of Conduct (industry viewpoint)
    • PIC/S (Pharmaceutical Inspection Convention/Pharmaceutical Inspection Co-Operation Scheme)
  • Consequences of noncompliance
    • FDA:
      • Application Integrity Policy
      • Disqualification of Clinical Investigators
      • Civil and criminal sanctions
      • Case study: Consent decree imposed on a company outside the US; implications of extraterritorial jurisdiction asserted by FDA
    • EMA/MHRA
    • Other agencies
    • Business consequences – Case study examples
  • Steps to take to prevent, detect and react to data integrity problems
    • Fundamentals of good documentation practice
    • Retention of true copies in lieu of originals – is it allowed, and if so, what are the expectations?
    • Signs you may have a data integrity problem
    • How to react if you suspect deliberate falsification
    • Involving legal counsel and external expert assistance
    • Considerations for voluntary disclosure to regulators (with concurrence of legal counsel)
  • Questions, general discussion, summary and wrap up

Meet Your Instructor

David L. Chesney
David L. Chesney
Principal and General Manager, DL Chesney Consulting, LLC (Former FDA Director)

David L. Chesney is the Principal and General Manager of DL Chesney Consulting, LLC.

His career includes 23 years with the FDA and over 21 years in GMP and GCP consulting worldwide. In his consulting practice, Mr. Chesney helps clients prevent quality and compliance problems through proactive assessment and planning, and when necessary, with remediation planning and health regulatory authority communications.

Until recently, he served as Vice President, Strategic Compliance Services for PAREXEL Consulting, a business unit of PAREXEL International LLC. Prior to joining PAREXEL Consulting in 1995, Mr. Chesney served 23 years with the FDA, where he advanced from Investigator to Supervisory Investigator and Director, Investigations Branch, working in the Boston, Seattle and Philadelphia District Offices. In 1991, he was appointed the District Director, FDA San Francisco District Office, where he served until joining PAREXEL in 1995. For 19 years, he led the Strategic Compliance Consulting group, and also personally provided regulatory enforcement related consulting services to the pharmaceutical, medical device and biologics industries, plus technical assistance to legal counsel in FDA regulatory matters. Mr. Chesney has a bachelor's degree and postgraduate credits in biology from California State University, Northridge and San Diego, and received a Certificate in Health Care Compliance from Seton Hall University School of Law.

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