ICH Q8: QbD in Manufacturing
Overview
The ICH Q8 guideline ensures a systematic approach to pharmaceutical development by defining globally recognized Quality by Design (QbD) principles to enhance product quality throughout all stages of development.
This course provides a comprehensive overview of Quality by Design (QbD), emphasizing its science-and-risk-based methodology with a patient-centric focus specifically tailored to enhance manufacturing processes. Participants will gain a thorough understanding of QbD terminology, key steps, and the advantages it offers. Additionally, it covers regulatory and industry guidelines, offering valuable insights into linking QbD with the Process Validation lifecycle, including references to influential resources such as the ISPE PQLI Guides.
Course Modules/Learning Objectives
- Foundations of ICH Q8 and Quality by Design (QbD)
- Core Concepts and Terminology QTPP and CQAs
- Understanding CPPs and CMAs
- Main DoE Example - Dissolution Response Surface
- Analysis Risk Assessment using FMECA
- Control Strategy
- Process Validation
- Continuous Improvement
Interactive Course includes:
- Immersive Videos
- Engaging graphics
- Reference materials and links to regulatory information
- Assessments to measure your comprehension
- The ability to start and stop at any time, beginning where you left off
CEUs are provided once you achieve an 80% passing grade and complete the evaluation.
The course is self-paced. On average, the time required for completion ranges from 1 to 3 hours.