Technical
Training
Hands on Practical Workshop
Expert
Consultancy
QbD-Expert™ conducts an exclusive Training Workshop for
Theoretical Training of all the tools & tactics of QbD with hands on Practical Workshop
uniquely tailored to meet customer specific needs for Quality by Design based Development of
Solid Oral (Tablet, Hard Gelatin Capsules, Soft Gelatin Capsules), Liquid Oral (Solution, Suspension, Emulsion).
Semisolid External (Cream, Ointment, Paste, Gel) & Parenteral (Injections, Infusions) Dosage Forms.
QbD-Expert™ provides complete "S" suite of Consulting Services for Development & Implementation of Quality by Design System for Novel & Generic Drug Product; starting from
1) Prior Art Landscaping (Patents / Research & Review Articles) 2) Planning for Filing 3) Target Product Profile Definition
4) Determination of CQAs with Impact Analysis 5) Quality Risk Assessment for API & Excipients Material Attributes
6) Quality Risk Assessment for Processing Parameters of Mfg Process 7) Designing of Experiments
8) Design Space Development 9) Design Space Validation 10) Control Strategy Proposal
11) Statistical Process Control Charts & Process Trend Evaluation
12) Designing of Continuous Monitoring Plan