Monday, October 30, 2017

#يحدث_الآن
أقوى مادة علمية فى علم الــــ

Formulation and Developing Pharmaceutical generic product

Level I (Basic level)
Course Objectives:
The course intends to give valuable theoretical and practical insights about developing different dosage forms, assessment of these products, fulfillment regulatory affairs, exportation requirements and trouble shooting of different dosage forms.
Course Contents:
 ICH Q8
 Regulatory submission
 API specification
 Innovator selection and characterization 
 Pre-formulation steps including Phase I
 Formulation development including Phase II and Phase III
 Formulation assessment against innovator including Bio-equivalence & Bio-waiver studies

Level II (Advanced level)
Course Objectives:
Cover formulation development, package development, developing specifications, regulatory submission, scale up issues, trouble shooting for problems raised during development/scale up/production.

Course Contents:
 Effective formulation development and package development
 Quality by Design
 Documentation including (IPC, Product development report, Sampling plan, TTR, PBPR, and Mater formula)
 Formulation scale up
 Technology Transfer from R&D to Production
 Trouble shooting
 MOH re-registration requirements  
التسجيل بأسبقة الحجز على الرابط
https://goo.gl/forms/WubLS0Xssvvo3JUJ2
وأولوية الاتصال علي
01000508388
01001771520
01094434988
01099770699
وشكرا جزيلا ،، الى ان نلقاكم قريبا
Charisma Quality Solutions #supply_chain #Lead_Internal_audit #cGMP#Pharmaceuticals #HSE

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