The pharmaceutical industry is expected to make arrangements to ensure that the accuracy, completeness, content, and meaning of data are retained throughout the data lifecycle. Failure to adhere to regulatory expectations can lead to recall, warning letters, import bans and criminal action.
This webinar will be a detailed discussion about GMP Data Integrity Best Practices and Regulatory Expectations for the Pharmaceutical Industry. We will also review the New MHRA GMP Data Integrity Definitions and Guidance Release in January & What to Expect from the FDA in the Future.
Areas Covered in the Session :
Data Integrity – Overview
The impact of data integrity issues
Where can data integrity failures happen?
How to know when it happens
Intentional and unintentional types of failure
How to get to the root cause of data integrity failures
The long slow route to repairing the damage of failures
What the EU is saying via the MHRA guidance
Warning letters tell you how it is detected by the FDA
How to prevent data integrity failures from happening
Who Will Benefit:
Quality Assurance Department
Quality Control Department
Compliance Auditors and Management
Process Development Scientists and Management
Supply Chain and Logistics Managers
Regulatory Affairs Professionals
Pharmaceutical Manufacturers of Solid Dosage, Vaccines, Biologics
IT Management and Staff working in Regulated areas