Course description
How easy is it to integrate continuous processing into manufacturing your biological drug, and what are the benefits and disadvantages?
Over the course of two days you will build on your understanding of how to effectively develop a continuous process and navigate the regulatory framework associated with it. Using interactive exercises and case studies to consolidate your knowledge, you will evaluate whether adopting a continuous process is the right decision for your manufacturing department.
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Suitability - Who should attend?
This course is should be attended by anyone who works in biopharmaceutical manufacturing and is considering adopting a continuous process.
Relevant departments would include: management, process validation, process engineering, quality assurance, regulatory control and manufacturing management.
Training Course Content
- Learn important definitions and advantages and disadvantages to continuous manufacturing, including increased efficiency and real-time analytics
- Understand how to develop a continuous process, including upstream and downstream aspects
- Familiarise yourself with the regulatory landscape and important ICH guidelines
- Learn what equipment is needed for continuous manufacture and the importance of cleaning specifications in continuous processing
- Understand the importance of quality assurance and process validation for continuous production, as well as consider key differences with batch manufacture
Why choose PTI
On average, delegates of their online academies said:
Quality of content:
4/5
85% had applied content during the course to their role
Delivery rating:
4/5
Reviews
Average rating 5
Content was great with lots of detail and with clear, concise delivery
The course covered the whole continuous process from early phase to commercial stage. This was very useful