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Quality assurance I

  • School / Prep

    ENSTBB

Internal code

BT6ASSQU

Description


Understand the stakes involved in Quality, why it is omnipresent and how it is integrated into daily life.
Understand the regulatory framework and the various quality standards that are essential to the pharmaceutical industry.
Understand common Quality tools and know how to use them simply.
Use Quality tools in various projects.
Participate in the implementation of a quality approach.

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Further information

The regulatory framework and basic concepts of the Quality approach:

Why Quality and the regulatory framework?
Standards and regulatory bodies in the pharmaceutical industry.
Common Quality tools and principles.
A few practical tips on how to apply Quality on a daily basis.

Putting the Quality approach into practice:

Workshops in small groups: investigation of practical cases (real problems encountered during practical exercises, examples of problems commonly encountered in industry).

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Assessment of knowledge

Initial assessment / Main session - Tests

Type of assessmentType of testDuration (in minutes)Number of testsTest coefficientEliminatory mark in the testRemarks
Integral Continuous ControlActive Participation1