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

Topics

• 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

Who should Attend

• 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