QbD-Expert™ provides online | offline | onsite QbD Training, hands-on DoE | QbD | SPC Practical Workshop & full-fledged DoE | QbD | SPC  Project Consultancy Services for Quality by Design.
QbD-Expert™ also offers an unique world-class Software Solutions for Designing, Development & Implementation of Quality by Design (QbD) system for variety of pharma / biotech dosage formulations for NDA & ANDA / MAA- Applications to USFDA, EMA & PMDA.

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Using 6 Basic Modules  of QbD-Expert™ with its 24 Advanced Tools like PMT, CVR, IA, SIPOC, RMA, FMEA, DoE, DSG, DC, SUD, PAT, PQ, Pp, Ppk, CSI, PV, Cp, Cpk, CCS, CCG, TA & Pσ; Scientists can:

 

• Define Quality Target Product Profile (QTPP) & Schedule Project Management (PMT) Activities,

• Determine the In Process & Finished Product Critical Quality Attributes (CQAs) with Safety &/or Efficacy  Impact Analysis,

• Qualitatively & Quantitatively Assess Risk Factors associated with Material Attributes (MAs) & Process Parameters (PPs) with respect to CQAs,

• Design of Experiments (DoE), Randomization, Replication, Blocking, Execution, Measurement of Responses(s), Regression Model Analysis for Screening &/or Optimization of CMAs &/or CPPs,

• Develop Design Space to optimize ranges of feasibility through Numerical (Desirability) & Graphical (Overlay) Optimization,

• Design Off Line, At line, On line & In line Process Analyzing & Controlling System/ Tools of PAT,

• Execute Scale-Up / Exhibit Process & Calculate Process Performance Indices

• Implement Control Strategies (CS) for CMAs & CPPs for Commercial Mfg.

• Validate Commercial Process & Predict Process Capabilities with Psigma

• Continuously Monitor & Incrementally Improve Mfg. Process.

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