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In pharmaceutical and API production, suitable equipment and premises are
essential prerequisites for manufacture in conformity with GMP. Here, it
is important to combine technical know-how with the interpretation of
pharmaceutical regulations and guidelines. The Pharmaceutical Engineering
Manager has the necessary skills for this task. In order to obtain this
certificate, the applicant must attend a total of 3 of the following
courses.
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Calibration / Measuring Technology in the Pharmaceutical Industry
or
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Measuring Technology for the Pharmaceutical Production
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FDA and EU-GMP Compliance for Cleanrooms
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FDA- and GMP-compliant Design of Equipment
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FDA-/GMP-compliant Water Systems
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Sterile Manufacturing - GMP/FDA-compliant
Qualification and Validation
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Clean Rooms
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Validation of Isolators
As an alternative, to obtain the certification one can attend the 4-day
intensive course "Pharmaceutical Engineering" as well as 1 of the
above-mentioned courses.
The following link leads you to upcoming
events recognised for the
Certified
Pharmaceutical Engineering Manager (ECA).
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