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.
Live Online Academies
Gain real-time access to a subject matter expert delivering online training in a structured virtual classroom environment. Live online academies are virtual versions of some of our most popular face-to-face courses.
Over 3 days students will learn through:
- Live interactive bitesize sessions
- Direct interaction with the trainer during live sessions
- Participation in interactive features within sessions including polls, Q&A, break out rooms, tasks, case studies, and more
- Interaction with peers during live sessions and through the online forum
Timings and dates are subject to change - final confirmation will be provided with login details. Delegates will receive login instructions within a week of the course start date. If you have any questions please contact Angel.Huertas@informa.com
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
Merck Serono SA
The content covered my needs. Lots of topics were covered with examples.
Delegates of our live online academies said...
would attend another live online academy
found the course beneficial to their day to day role
would recommend the course to others