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

mithun.siddartha@biiworld.com

+1 780 851 7197 (Canada)