Pricing is coming soon
The aim of this two-day masterclass is to provide an insight into the pharmaceutical product and process life cycle concept. 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).
High attention will be on the Quality by Design approach and the establishment of the Control Strategy that drives scale-up, technology transfer, qualification, validation, commercial operation and continual improvement
The lifecycle approach to validation including the regulatory expectations
Review the science and risk-based approach to pharmaceutical development and process design
Understand how to apply QbD principles for process design, qualification and control
Review Quality Risk Management principles and tools and why they are important