Data Integrity and Document Management

Topics

• 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

Who should Attend

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