Overview

The aim of this two-day masterclass is to provide an insight into the pharmaceutical product and process life cycle concept. Discuss pharmaceutical process development using QbD principles, establishing the control strategy, transfer of the process into commercial operations, validating it and being able to execute it for routine production – product realisation (manufacture and release products).

High attention will be on the Quality by Design approach and the establishment of the Control Strategy that drives scale-up, technology transfer, qualification, validation, commercial operation and continual improvement

Trainer Profile

Line Lundsberg runs her own consultancy business supporting clients in developing and manufacturing pharmaceutical products. She has spent more than 20 years within the pharmaceutical Industry (API & Drug Product Development and Manufacturing). She is specialised in the science and risk-based concept of Pharmaceutical Development and Manufacturing including Quality by Design (QbD), Process Analytical Technology (PAT), Process Validation lifecycle (PV), Good Manufacturing Practise (GMP), Quality Risk Management (QRM) and the related regulatory and compliance aspects. Her main consulting areas are Regulatory Expectations, Future pharma trends in smart manufacturing & control, Quality by Design (QbD), Process Analytical Technology including Real Time Release Testing, Process Validation, and Good Manufacturing Principles combined with science and risk based innovative development and manufacturing.

She was one of the pioneers that together with the FDA, EMA and the ASTM standard organisation took part in developing the Science and Risk based framework that today is the new foundation for product development and manufacturing in the pharmaceutical and biotech industry. She is active in ISPE, a global trainer in QbD and Process Validation and is known to be a well-recognised speaker at international conferences and events.
 

Course Key Takeaways

The lifecycle approach to validation including the regulatory expectations

Review the science and risk-based approach to pharmaceutical development and process design

Understand how to apply QbD principles for process design, qualification and control

Review Quality Risk Management principles and tools and why they are important

Who should Attend?

VP/ Director/ Manager/ Supervisor/ Chief/ Expert

  • Pharmaceutical Development
  • Process Design
  • Process Validation
  • Process Control
  • Process Support
  • Process Engineering

PRICING & REGISTRATION

    Pricing is coming soon

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CONTACT PERSON

In-house opportunity

We can come to you too! If you have a team of six or more, why not hold a private course?

For more details:

Call +44 2080687649 (United Kingdom) 
Email : inhouse@biiworld.com