Shanti Marlina Sibuea

Topics of Expertise

Halix Netherland Halix Netherland

Get To Know Shanti Marlina Sibuea

More than 10 years’ experience as GMP Inspector and have been inspecting hundreds of pharmaceutical production facilities throughout the world including vaccines, biosimilars, cytotoxic, hormones, beta lactams and other medicinal product manufacturer. More than 5 years' experience in reviewing Site Plan including lay-out personnel and material and facility design of pharmaceuticals and biologicals manufacturer WHO Expert/Trainer/Facilitator/Temporarily Advisor for Good Manufacturing Practices (GMP), have been teaching in GMP workshops among others for China and India GMP Inspectors. Pharmaceutical Inspection Cooperation Schemes (PIC/S) Assessor of Accession of Thai FDA to PIC/S 1 year worked for optimization and characterization and study in-vitro release kinetic of nano and microparticle loaded with Antigen and Adjuvant

Experience

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GMP Inspector
Badan Pengawas Obat dan MakananJan 2006Present

Education

University of Leiden
Master of Biopharmaceutical Science
University of Leiden20112013
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