Data Integrity and Document Management is a conference that covers topics such as:
- Data integrity criteria and definitions eg ALCOA
- The importance of document management and data integrity
- QMS considerations for data integrity
- Key regulations and guidelines MHRA / FDA/ EMA/ PICS / ICH GCP R2
- The requirements for data integrity governance to prevent data integrity breaches
- Data integrity inspection findings to check for compliance against data integrity expectations
Data Integrity and Document Management brings together managers and staff from clinical research and other GXP areas in the pharmaceutical and medical device industries with responsibilities in:
- Regulatory affairs
- Clinical research
- Legal and compliance office
- Quality assurance / quality control
- GMP compliance officers
- Compliance manager
- Heads of internal audits
Data Integrity and Document Management will be held on 12 Apr 2024.