Specialized training in QbD, DoE, PAT, QRM and other pharmaceutical development methodologies. We offer tailored workshops for teams across development and manufacturing.
Quality by Design (QbD)
- Framework overview (Q8–Q14), CQAs/CPPs, design space, control strategy
- QbD tools, DoE, PAT, risk management, scale effects
- Implementation for drug substances, products, and analytical methods
Design of Experiments (DoE)
- Statistical foundations and experimental planning
- Full and fractional factorial designs; ANOVA and regression
- Response Surface Methods (Box‑Behnken, CCD), mixture design
- Design space establishment with 95% CI; verification
Process Analytical Technology (PAT)
- IR, NIR, Raman, UV/VIS, MS; qualitative/quantitative methods
- Chemometrics overview; model building and validation
- Applications: reaction monitoring, polymorphism, blend/content uniformity, moisture
Quality Risk Management (QRM)
- Risk identification, analysis, evaluation, and control
- Tools: FMEA, HACCP, HAZOP
- Benefits: cost reduction, efficiency, customer confidence
Statistical Process Control (SPC)
- Data types, dispersion, plotting (box/histogram/scatter)
- ANOVA, hypothesis testing, correlation and regression
- Process capability (Cp, Cpk) and improvement reviews
Scale-up (Formulation)
- Transition from laboratory to pilot/commercial plant scale
- Process parameter optimization and validation
- Equipment selection and facility considerations
- Regulatory compliance during scale-up
In Vivo In Vitro Correlation (IVIVC)
- USP–NF <1088> guidelines and requirements
- Dissolution testing methodologies and protocols
- Bioavailability (BA) and bioequivalence (BE) study design
- Biopharmaceutics Classification System (BCS) categorization
- Correlation levels (A, B, C) and their applications
- IVIVC application in regulatory submissions
