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Data Integrity: FDA/EMA Requirements and Implementation

Event Details

Data Integrity: FDA/EMA Requirements and Implementation

Time: July 14, 2021 at 11am to July 15, 2021 at 5pm
Location: online
Street: Compliance Online, 2479 E. Bayshore Road
City/Town: Palo Alto
Website or Map: https://www.complianceonline.…
Phone: 8887172436
Event Type: seminae
Organized By: ComplianceOnline
Latest Activity: May 31

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Event Description

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

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

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