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Bioprocess Characterisation, Qualification and Validation

Course summary
2 weeks
Online courses
Professional Training

Course description

Bioprocess Characterisation, Qualification and Validation

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, participants 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. 

Suitability - Who should attend?

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

Outcome / Qualification etc.

This course will enable participants to:

  • Understand applicable ICH guidance’s to ensure your operations are compliant 
  • Improve your knowledge of process development
  • 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
  • Analyse process verification and validation

Training Course Content

  • Introduction to regulatory guidance
  • Traditional and enhanced pharmaceutical development

Why choose PTI

On average, delegates of their online academies said: 

Quality of content:


85% had applied content during the course to their role

Delivery rating:


About provider

PTI - Pharmaceutical Training International

PTI - Pharmaceutical Training International - Training for the Pharma Industry

PTI is the global leader in professional education for the pharmaceutical industry, delivering a broad course portfolio that covers the industry spectrum: R&D, Clinical Development, Generics, Bio-pharmaceuticals, fine Chemicals, Agro-chemicals, Medical Devices, Animal Health, Manufacturing and Regulations. PTI's open courses,...

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Average rating 5

Based on 4 reviews

Associate Engineer
It was a great experience. I learned a lot about process validation.
Project Manager, Merek Serono SA
The content covered my needs. Lots of topics were covered with examples.
Global Regulatory Affairs CMC Manager, Bayer
The pactical exercises and group work were very useful
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Course rating
Based on 4 reviews
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