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