In the European Union (EU), the Good Manufacturing Practice (GMP) requirements place specific obligations on manufactures of medicinal products to implement risk-based qualification, validation and change control programs.

The Handbook to GMP Training, Compliance & Risk Management Solutions: A European Perspective, highlights the need for patient focused & value adding qualification, validation & change control programmes for manufacturing and regulatory which are cost effective & in line with current regulatory requirements.

T A B L E  O F  C O N T E N T S
Handbook To GMP Training, Compliance & Risk Management Solutions: A European Perspective

GMP Training And Compliance Strategies:
A European Perspective
By Kay O'Hagan

A Risk Management Solution Designed To Facilitate Risk-Based
Qualification, Validation, And Change ControlActivities Within GMP
And Pharmaceutical Regulatory Compliance Environments In The EU
Part I: Fundamental Principles, Design Criteria, Outline Of Process
By Kevin O'Donnell and Anne Greene

A Risk Management Solution Designed To Facilitate Risk-Based
Qualification, Validation, And Change Control Activities Within GMP
And Pharmaceutical Regulatory Compliance Environments In The EU
Part II: Tool Scope, Structure, Limitations, Principle Findings, And
Novel Elements
By Kevin O'Donnell and Anne Greene

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