Brahim Senan

Background

About Brahim Senan

Professionnel en sciences pharmaceutiques, ayant + plus de 16 ans d’expérience dans l’industrie pharmaceutique: Formulation & Développement de médicaments/ Optimisation et validation des procédés de fabrication stériles et non stériles.+Plus 9 ans d’expérience dans la conformité réglementaire et l’application de la Loi (Aliments & Drogues, Produits de santé naturelles, instruments médicaux, Substances controlées et Cannabis ) au sein de Santé Canada. REALISATIONS: Currently I am regional compliance & enforcement Specialist, at Health Canada.*Provide training & technical assistance to inspectors,*Participate in working Groups to ensure applicable Acts and its regulations are followed and provide recommendations to ensure a national consistency and application,*Review & approve inspection reports,*Lead and conduct the Rapid Root Cause Analysis to any Process and/or Quality system Deviation & Customer Complaints *Process Improvement (Sterile, Lyophilisation, Solid Oral Drugs and Medical Devices)*Prepare Process Validation Protocols & Rapports -Rapid root causes Analysis for incidents and CAPA managing -Lead of the recall processes -Act with committee to approve artworks for packaging material -Prepare the technical documents for health canada to up-date the licences for Controled Substances - Formulate a new Per os dried drug pruduct for clinical studies -Audit & review of MBR (sterile, Lyophilized products, liquid & dry formulas)-Scal up and technical transfer to GMP facilities-Create and approve the Manufacturing and Packaging master files for clinical batches-SOPs writing and specifications -Perform the Annual Product Quality Review (APQR)-Conduct the Quality audits and suppliers qualification -Provide impact assessment of the change controls -QPIC for Narcotics