Job Description

New Chapter: Quality by Design (QbD) in Biopharmaceutical Development

✳️ Definition of QbD
Quality by Design (QbD) is a systematic, science- and risk-based approach to pharmaceutical development. It begins with predefined objectives and emphasizes deep product and process understanding, along with robust process control.
📜 Regulatory Guidelines on QbD
QbD principles are strongly recommended by global regulatory authorities and guided by:
International Council for Harmonisation (ICH) guidelines
U.S. Food and Drug Administration (FDA) expectations
European Medicines Agency (EMA) requirements
Key ICH Guidelines:
ICH Q8 (R2): Pharmaceutical Development
ICH Q9: Quality Risk Management
ICH Q10: Pharmaceutical Quality System
ICH Q11: Development and Manufacture of Drug Substances
🔑 Key Elements of QbD
1️⃣ Quality Target Product Profile (QTPP)
Prospective summary of product quality characteristics
Ensures safety, efficacy, and overall product quality
2️⃣ Critical Quality Attributes (CQA)
Physical, chemical, biological, or microbiological properties
Must be controlled within predefined limits
3️⃣ Critical Process Parameters (CPP)
Process variables impacting CQAs
Examples: temperature, pH, flow rate
4️⃣ Critical Material Attributes (CMA)
Raw material properties affecting process performance
Examples: media components, resins, filters
5️⃣ Risk Assessment Tools
FMEA (Failure Mode and Effects Analysis)
Ishikawa (Fishbone) diagrams
Used for risk identification and prioritization
6️⃣ Design Space
Multidimensional combination of input variables ensuring product quality
Provides regulatory flexibility when operated within approved limits
7️⃣ Control Strategy
Planned controls based on process understanding
Includes in-process controls, specifications, and monitoring
8️⃣ Continuous Improvement & Lifecycle Management
Continuous Process Verification (CPV)
Lifecycle approach aligned with regulatory expectations
📊 Regulatory Expectations & Industry Perspective
Enhanced process understanding reduces batch failures
Enables smoother regulatory approvals and lifecycle changes
Strongly encouraged for biologics, vaccines, and biosimilars
Supports robust CMC (Chemistry, Manufacturing, and Controls) documentation
🎯 Learning Outcomes
By the end of this module, participants will be able to:
Apply QbD principles in biologics development
Develop QTPP and identify CQAs, CPPs, and CMAs
Perform risk assessments and define design space
Build control strategies aligned with global regulatory expectations
📈 Biostatistical Tools Covered
Minitab
JMP
ANOVA applications in process optimization
🧬 Advanced Regulatory Topics
Cell & Gene Therapy – CMC & regulatory strategy

📅 Batch Details
🗓 Start Date: 06 April 2026
⏰ Time: 20:30 – 22:00 IST
💻 Mode: Live Online (Zoom)
📩 Contact & Registration
📧 Email: fortuneveda@gmail.com
🌐 Website: www.fortunateveda.com
📱 WhatsApp: +91-8603223334