16 Aug 2018
CAPA and Change Control Management
Achievements Review of CAPA and Change Control management processes Follow-up and closure of CAPA Resorption of the Change Control backlog Improved Change…
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13 Aug 2018
Development of a Validation Strategy / Manage...
Achievements Development of a validation strategy Priorisation of qualification and validation activities Site Validation Master Plan Planning of qualification and validation activities Update…
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13 Aug 2018
Qualification of 7 Fabrication Platforms -OTC...
Achievements 7 Validation Master Plan 7 Risk analysis Installation qualification with déviations and CAPA Management Operational Qualification protocols and planification of OQ…
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13 Aug 2018
Installation of a new Aseptic Filling Line
Achievements Planning of commissioning and qualification activities Management of project progress Review of quality documents for the different batches (production equipment and…
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13 Aug 2018
Validation of Cleaning Equipment Manufacturin...
Achievements URS in order to consult suppliers Cleaning validation plan with the development of the validation strategy Toxicological evaluation with PDE determination…
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13 Aug 2018
Process Validation – Dry Forms
Achievements Process risk analysis with identification of critical process parameters (CPP) and critical quality attributes (CQA) Development of the process validation strategy…
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