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
The aim of this 4 Day Online Course on QBD (Quality by Design) is to provide an insight into the pharmaceutical product and process lifecycle concept. The course covers both small and large molecules, i.e. both biotech process (upstream, downstream), chemical pharmaceutical API and drug products and is based on EU and US regulations supported by ICH.
We will discuss pharmaceutical process development using QbD principles, establishing the control strategy, transfer of the process into commercial operations, validating it and being able to execute it for routine production – product realisation (manufacture and release products). The training will be interactive with a combination of course lectures and group exercises.
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
- Application of QbD principles for process design, qualification, and control.
- Lifecycle approach to validation including the regulatory expectations.
- Science and risk-based approach to pharmaceutical development and process design.
- Validate a process including justifying the number of validation batches.
- Establish an ongoing process verification program for new and legacy products
Who Should Attend
(Job Titles)
- Production Manager
- Pharmaceutical Development
- Process qualification and validation
- Quality Assurance (All)
- Quality Control Manager/Supervisor
For participation details contact
Mithun Siddartha
+1 780 851 7197 (Canada)