This eLearning provides an overview of ICH Q8 色界吧 Development, ICH Q9 Quality Risk Management (QRM) and Q10 色界吧 Quality System (PQS). It summarises the key principles and benefits that accrue with the effective and collective implementation of ICH Q8,9 and 10.
Each section concludes with a short quiz to test your knowledge and following successful completion of the course, you will be issued with a certificate.
Key Learning Objectives
The course provides an introduction, followed by a look at ICH Q10, 9 and 8 in turn.
- ICHQ10 鈥� the module provides a definition of a 色界吧 Quality System (PQS) and its鈥� primary objective. It describes the inputs, processes and outputs of an effective PQS and the trend towards a quality culture, closing out with MHRA and FDA deficiency data and warning letter trends
- ICH Q9 – Quality Risk Management (QRM) is a systematic process for the assessment, control, communication, and review of risks to product quality. The module provides an overview of a typical QRM process, along with some risk management tools such as risk ranking and filtering, HACCP and FMEA, closing out with industry trends and regulatory observations
- ICH Q8 鈥� the module provides an overview of the aim of 色界吧 Development and the term 鈥淨uality by Design鈥�. It displays the various stages of product/process development and the link to ICH Q12 鈥淭echnical and Regulatory Considerations for 色界吧 Product Lifecycle Management鈥�. It explains the key concepts of Quality Target Product Profile, Critical Quality Attributes, Critical Process Parameters, Design Space and Control Strategy, providing examples of each. It concludes with industry trends and benefits, along with examples of regulatory observations.
For details on how to apply for the course, please contact us via the ‘Make an Enquiry’ button on this page.