This Pharmaceutical Product & Process Lifecycle Management two day course aims to provide an insight into the pharmaceutical and biopharmaceutical product and process lifecycle concept. Discussion on pharma trends towards a higher complexity of multiple, specialized products with a smaller volume combined with technology trends such as continuous manufacturing and digitization towards manufacturing based on Industry 4.0 principles.

The fundamentals for implementing and managing modern manufacturing is a robust pharmaceutical quality system and design of high-quality products associated with robust manufacturing processes. The course will cover those elements based on ICH Q8-14: Quality by Design, Quality Risk Management, Pharmaceutical Quality System and Product Development. The course will be interactive with a combination of course lectures and group exercises. The regulatory languish applied during this course will be as defined by the EU regulations (EMA Guidelines and EU GMP) however, when it differs from terms used by US FDA it will be highlighted.

Trainer Profile

She 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 new pharma reality and trends such as new in product types incl personalised medicines (ATMPs), new manufacturing concepts incl continuous manufacturing, digitization and Industry 4.0

The science and risk-based approach to pharmaceutical development and process design

How to apply QBD principles for process design, qualification, and control

The principles of Design of Experiments, Process Analytical Technology used for gaining process understanding and controlling the process

Quality Risk Management principles and tools and why they are important

The importance and power of the control strategy, how to establish and maintain it throughout the lifecycle

Who should Attend?

You will benefit from attending this course if you are a scientific professional with an intermediate level of experience from job functions like Development, Technical Support, Manufacturing, Quality Control, Quality Assurance, Regulatory Affairs, Engine

  • Manager Drug Product Development
  • Principle Formulation Scientist
  • R & D Directors
  • CMC Managers
  • Product Technology Specialist
  • Biotechnology Specialist


    Pricing is coming soon

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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 +1 780 851 7197 (Canada) 
Email : inhouse@biiworld.com