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Bioprocess Characterisation, Qualification and Validation

Gain a strategic approach to continual process improvement

2-day course | 12 - 13 February 2019

Radisson Blu Edwardian Grafton, London

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.

  • Understand applicable ICH guidances to ensure your operations are compliant
  • Learn to apply the principles of QbD and appreciate the advantages and disadvantages of a QbD approach
  • Examine the stages of process development
  • Evaluate small-scale process models and understand their limitations
  • Learn how to assess and manage risk
  • Apply a process control strategy and discuss how to set limits and ranges
  • Construct a take away spreadsheet to help you implement a process control strategy back at your facility

This course is relevant for professionals who directly work in biopharmaceutical manufacturing or for those professionals who would benefit from a greater understanding of process characterisation, qualification and validation activities and requirements. Relevant departments may include:

  • Technicians
  • Process scientists
  • Scientists
  • Management
  • Supervisors
  • Bioprocessing Engineers
  • Production operations
  • Project leaders
  • Regulatory affairs
  • Quality assurance/control
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Dr Margit Holzer


Margit is a specialist in process, product and analytical methods development for preclinical and clinical production phases as well as for commercial supply.

After completing her doctorate in Vienna, Margit began working at Boehringer Ingelheim, eventually establishing and becoming the head of the new division of manufacturing sciences. She moved on to become the Quality Director and later on the Technology, R&D and Innovation Director for NOVASEP in France, before setting her own consultancy. She now assists clients in the evaluation, optimization and development of processes, analytics and technologies including innovative ones for Up & Downstream processing and Formulation. She has 25 years of experience in the industry and worked on more than 50 different products.

"The discussions and interactions we had with our peers and the trainer was excellent."

 - Senior Scientist, Ablynx

"The practical exercises and group work was very useful."

 - Global Regulatory Affairs CMC Manager, Bayer

The content covered my needs. Lots of topics were covered with examples.


Project Manager, Merck Serono SA

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