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