as of 2018 - 12 - 03

7.B Validation – a key element in a QM system

7.B Validation – a key element in a QM system
Here you will find answers to the following questions:

What is the purpose of validation? What are its objectives?

How significant is validation in the quality management system?

What is the difference between validation, qualification and verification?

How has the concept of validation developed over time?

Who is obliged to carry out validation?

What errors typically occur during validation?

In what ways does the life cycle model differ from previous approaches to validation?

What is traditional validation? What is a hybrid approach?

Is the traditional approach still acceptable? What needs to be observed in future?

How does continued process verification or ongoing process verification differ from continuous process verification (CPV)?

What roles do QbD (Quality by Design) and PAT (process-analytical technologies) have in the context of validation?

How does the approach taken by the FDA guideline on process validation differ from the validation concept of the EMA?

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