15-16 October 2019
Radisson Blu Edwardian Kenilworth,
Bioprocess Characterisation, Qualification and Validation
On this 2-day course you will develop a deep understanding of bioprocessing to ensure quality and compliance
A successful, cost-effective and compliant process can be difficult to achieve. With the latest guidances promoting a lifecycle approach to validation, it is essential to develop a strong understanding of associated activities. This course is intended to provide a complete understanding of process development, characterisation, qualification, verification and validation to ensure efficient and compliant bioprocessing facilities.
Starting with an overview of relevant guidance documents, delegates will move on to understand Quality by Design (QbD) and how it can be applied to industry. The course will provide in-depth coverage of control strategy and process performance qualification, verification and validation. You will learn through a mixture of presentations and case study exercises to solidify your understanding. You will also construct a practical spreadsheet on process control which can be taken away for use in your day-to-day role.
What will you learn?
Understand applicable ICH guidances to ensure your operations are compliant
Quality by Design
Learn to apply the principles of QbD and appreciate the advantages and disadvantages of a QbD approach
Examine the stages of process development and evaluate small-scale process models to understand their limitations
Learn how to assess and manage risks to bioprocessing
Process control strategy
Apply a process control strategy and discuss how to set limits and ranges - you will construct a take away spreadsheet to help you implement a process control strategy back at your facility
Who is this course for?
This course is relevant for professionals who work in biopharmaceutical manufacturing or who would benefit from a greater understanding of process characterisation, qualification and validation requirements. Relevant departments may include:
- Process scientists
- Bioprocessing engineers
- Production operations
- Project leaders
- Regulatory affairs
- Quality assurance/control
The content covered my needs. Lots of topics were covered with examples.
Merck Serono SA
The practical exercises and group work were very useful.
Global Regulatory Affairs
The discussions and interactions we had with our peers and the trainer were excellent.