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Bioprocess Characterisation, Qualification and Validation

16 - 17 October 2018

Radisson Blu Edwardian Grafton, London

The biotech industry has grown significantly with the majority of new novel medicines being biopharmaceuticals, such as monoclonal & polyclonal antibodies, recombinant DNA proteins and viral gene therapies. This course will provide delegates with a complete understanding of process development, characterisation, qualification, verification and validation to ensure efficient and compliant bioprocessing facilities.

Quality by Design (QbD) is becoming increasingly important throughout industry, including in biopharmaceutical manufacturing. Over two days you will gain an introductory overview of QbD and understand how to utilise small-scale models, assess risk and be compliant with current EU regulations.

  • 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 development such as;

  • Technicians
  • Supervisors
  • Bioprocessing Engineers
  • Process scientists
  • Scientists
  • Management
  • Production operations
  • Regulatory affairs
  • Quality assurance/control

Dr. Anders Christensen
Anders is a pharmaceutical scientist focusing on CMC with 20+ years of experience in R&D and in the pharmaceutical industry. His experience ranges from the planning for the pre-clinical batches, to commercial manufacturing, and from planning of experiments to validation and preparation of regulatory files.

Anders began his career in research at the University of Copenhagen. Following this, he worked as a CMC scientist, before becoming an independent consultant. Anders offers CMC and related services in Biologics and Biosimilars using his background in bioprocess techniques, regulatory requirements and statistics. He advises on process development, process validation, QbD, analytical troubleshooting and CMO selection/management.

"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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