Course Overview

This course will be dealing with more visionary aspects of modern and future QC methods. This includes QbD and PAT, technologies that are gaining more and more ground in the pharmaceutical industries. Model supported process prediction including CFD methods for design space descriptions will be introduced as well as novel measurement techniques and the concept of digital twins for the potential use in continuous production of batch production processes. Finally, virtual processes and laboratories for process understanding and operator training will also be a topic. Here basic concepts of Artificial Intelligence (AI) and machine learning algorithms will be introduced.

Learning Outcomes

At the end of this course, participants should be able to:

• Describe novel digital methods and their use in GMP.
• Conduct basic CFD simulation of CIP processes  
• Compare novel software sensor systems and reflect on their potential benefits  
• Describe basic concepts of software sensors, digital twins for unit operations and processes and reflect on the benefits of such model supported control and monitoring aspects

Who should attend?

The course is intended for participants familiar with classical GMP procedures who want to learn about modern and future trends in QC methods. The course material is perfect for new employees, support personnel from Quality Control and Quality Assurance, and vendors and suppliers providing equipment and services to the industry. The course addresses all levels of education, including technicians, BSc and MSc.

This course is intended for individuals with background, skills, and/or experience in the following areas:

• Employees in biomanufacturing currently working with GMP who want to get more familiar with current trends in the field
• Scientists, engineers and technicians who are working with monitoring and control of bio-based manufacturing processes
• Vendors of auxiliary equipment for the bio-manufacturing industry
• Employees handling data management aspects of biomanufacturing operations
• Participants with a background in bio-based production holding a BSc, MSc or PhD degree.

Prerequisites 

Participants must have a laptop/computer where it is possible to install software or already have an installed modern web. We assume participants have basic knowledge about the general principles of biomanufacturing and downstream operations. Participants are expected to bring a laptop to work with case study examples.