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New Releases

Qualification and Validation: Agency Expectations
This report is a "must have" guidance for all those who are involved in qualification and validation: It provides information about regulatory requirements, risk management, life cycle concepts and much more.

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Data Integrity in the EU
Excerpt from the GMP Compliance Adviser

Requirements for Quality Management Systems - learn more about the principles of data integrity, systems to monitor data integrity and the storage and archiving of records.

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Principles of Equipment Qualification
Excerpt from the GMP Compliance Adviser

A Guide for Drug and Device Manufacturers - learn more about the four phases of qualification.

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gmp review
A quarterly publication which provides in-depth analyses of international pharmaceutical manufacturing regulations.

 
 
Top Ten Data Integrity Traps
How to Find and Fix Problems

A FDAnews publication

 
 
Managing Contract Manufacturers and Testing Labs
A comprehensive step-by-step guide, which covers all aspects of selecting and managing contractors.

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