Outsourcing Qualification

Outsourcing qualification activities to suppliers

What should an all-inclusive qualification package include?

What is the content of a contractor agreement?

What are the obligations of the contract giver and the contract acceptor?

Learn about the following topics in the feature today:

• Reconciliation of definitions and contents
• Definition of the scope of qualification
• Adaptation of the contract giver's qualification strategy
• Processing times for approving documents
• Use of subcontractors
• Certificates
• Handling of raw data
• Handling of changes and deviations

>>> Click here to read the feature "Transfer of qualification activities to suppliers" by Ulrike Reuter, Sanofi (Germany), Max Lazar, Consultant, (USA)

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GMP News: API Import Template

2012-05-23
EC: API Import Template (Draft)

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Recommend the LOGFILE

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You missed a LOGFILE?

• LOGFILE No. 16/2012 - Computer System Validation / The "V model"
• LOGFILE No. 15/2012 - GMP Risk Analysis RA 2x5
• LOGFILE No. 14/2012 - EMA Draft for Process Validation

Click here to see them all...