Data Integrity: FDA/EMA/TGA Requirements and Implementation 2017

  • 18-19 May 2017
  • Quay West Suites Sydney Hotel, Australia

Description

Data Integrity: FDA/EMA/TGA Requirements and Implementation 2017 is a seminar that covers topics such as:

  • The difference between innocent lapses and deliberate wrongful conduct
  • The meaning of the term data integrity and the importance of the acronym A.L.C.O.A. to regulatory agencies
  • Some of the common motivations for deliberate wrongful conduct that results in data falsification
  • Some of the key historical events that form the basis for regulators concerns about data integrity
  • The possible business and regulatory consequences of noncompliance
  • 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
  • The important steps to take to prevent , detect and react to data integrity problems

Data Integrity: FDA/EMA/TGA Requirements and Implementation 2017 brings together:

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

Past Events

Important

Please, check "Data Integrity: FDA/EMA/TGA Requirements and Implementation" official website for possible changes, before making any traveling arrangements

Event Categories

Business: Quality assurance
Health & Medicine: Healthcare, Medical device, Medical laboratories, Pharma

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