Course description
This course majorly covers an overview on Generic product development of oral solid dosage forms (OSD) with QbD perspective, Role of excipients and selection criteria in formulation development, Process optimization, scale up considerations and calculations, An overview on tablet film coatings & trouble shooting in film coatings, Role of Hot melt extrusion (HME) in pharmaceutical development, QbD in pharmaceutical development (over view on ICH Q8, Q9, & Q10), Current USFDA guidance for industry (Guidance for size &shape, SUPAC- IR/MR, BCS Bio-waiver etc.,), An overview on Regulatory requirement for US, Europe & Canada submissions.
Course Content
Course Duration: 30 classes
Duration of Each Class: 2hours
Total Duration: 60hours
This course majorly covers an overview on Generic product development of oral solid dosage forms (OSD) with QbD perspective, Role of excipients and selection criteria in formulation development, Process optimization, scale up considerations and calculations, An overview on tablet film coatings & trouble shooting in film coatings, Role of Hot melt extrusion (HME) in pharmaceutical development, QbD in pharmaceutical development (over view on ICH Q8, Q9, & Q10), Current USFDA guidance for industry (Guidance for size &shape, SUPAC- IR/MR, BCS Bio-waiver etc.,), An overview on Regulatory requirement for US, Europe & Canada submissions.
More information Contact: +91 9949596900
Course audience
pharma freshers and experince candidates
