Data Integrity and Documentation Excellence

Description

This course addresses one of the most cited areas in inspections: documentation and data integrity. It moves beyond theory to show how ALCOA+ must appear in real records, batch documentation, and electronic systems. Participants will see how shared passwords, backdating, and incomplete entries immediately undermine credibility. The module clarifies the practical relationship between paper controls and electronic record requirements, including Part 11 fundamentals. By the end, attendees understand how to design documentation systems that naturally withstand audit scrutiny and reduce the risk of integrity-related findings.

Agenda:

• ALCOA+ principles in practice
• Good Documentation Practices (GDP)
• Batch records and logbook controls
• Electronic records & 21 CFR Part 11 fundamentals
• Audit trails and system security
• Preventing backdating and unofficial records
• Designing documentation that withstands audits

This is Module 2 of Practitioner Course "GMP Master Class for Life Sciences".You can either sign up only for this Module here.Or the entire course → Here

Who This Training Is Designed For

• Quality Assurance Departments
• Quality Control Departments
• Manufacturing Departments
• Operations Departments
• Production Departments
• Regulatory Affairs Departments
• Validation Professionals
• Engineering Departments
• Compliance Specialists
• Training Managers
• Document Control Personnel