Quality by Design (QBD)
- Real Time Online Delivery – Live Training Sessions
- Virtual Attendance for 4 Days Training
- Guided Learning Hours – 16
- Case Studies, Exercises, Q & A,
- Pre-Course Access: Intro Session, Pre-Event Questionnaire, Presentation Slide Deck
Course Overview
This online course will cover the various aspects (Guidances and laws that cover QbD) from ICH, EMA, and FDA as well as the benefits and tools used for a successful program. It will also concentrate on the lifecycle management portions of ICH Q-11and Q-12. Topics will include Science and Risk-Based Approach to Product Lifecycle and Process Validation, ICH Q8-Q11 guidances, QbD Terminology and their concepts (QTPP, CQA, CPP), and Quality Risk Management. The 4-Day QBD Online Course will also cover some of the more important technologies used in QbD: Near-Infrared, Raman, and fluorescence spectroscopies, acoustics, LIBS (LASER-induced breakdown spectroscopy) and more.
Trainer’s Profile
Our expert has worked in the pharmaceutical industry since 1970, has been presenting short courses in the US, Europe, Asia, and South America on Near-Infrared, PAT/QbD, Process
Validation, and Design of Experiments. Has worked with industrial clients, aiding them in choosing the most effective technologies for their process monitoring and control programs (PAT/QbD). He also interfaces between the Pharma companies and instrument companies, helping configure instrumentation for the PAT applications of the clients.
Key Takeaways
- Key Learning: Which tests on which products should be first and will give the greatest payback for effort and cost.
- Lifecycle QbD: Allows the manufacturer to follow the vision of the Agencies: as the product ages, it is made better and better by understanding the process and modifying it over time.
- Build: Your team who is needed and from which department? Your system: which tools and
- software will give you a successful program.
Who Should Attend
(Job Titles)
- Production Manager
- R&D Personnel (tech and finance-minded)
- Quality Assurance (All)
- Quality Control Manager/Supervisor
- AR&D Method Development Personnel
- Product Design Personnel (formulators)
- IT Personnel (highly computer dependent effort)
- Statistics and Chemometric personnel (Highly dependent on both)
- Validation
- Regulators
For participation details contact
Mithun Siddartha
+1 780 851 7197 (Canada)