
Topics of Expertise

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
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