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Data Integrity: FDA/EMA Requirements and Implementation 2021 

Data Integrity: FDA/EMA Requirements and Implementation 2021

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

Contact Organizer

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(1+) 206-575-7771
World Medical Events Company
12922 SE 299th Street, Auburn WA 98092 USA