The Data Integrity: FDA, WHO and EMA`s Requirements 2016 is a course that covers topics such as:
- The key elements
- The fundamental causes of Data Integrity issues
- The various inspection approaches to monitor for Data Integrity
- How the regulations impact Data Integrity issues
- Why Data Integrity that is not reliable hints of a Company being outside of compliance and questions the quality of the product being produced
- Is there a right or wrong way to monitor for Data Integrity
- The consequences of questionable data and how they may lead to seizures, import alerts, etc
The Data Integrity: FDA, WHO and EMA`s Requirements 2016 brings together:
- Regulatory professionals
- Quality professionals
- Manufacturing engineers
- Compliance professionals
- Quality auditors
- Quality engineers
- Microbiology
- Quality Control
- Document control specialists