ICH Q10: Pharmaceutical Quality System (PQS)
The Pharmaceutical Quality System (PQS), as defined by ICH Q10, ensures product quality and continuous improvement throughout the lifecycle of pharmaceutical products.
Overview
This fundamental online course introduces the Pharmaceutical Quality System (PQS), which is a framework that ensures product quality meets established standards throughout the lifecycle of pharmaceutical products. It aims for suitable process performance by implementing robust controls for drug development and manufacturing, including quality assurance, risk management, and regulatory compliance. The system identifies improvement opportunities and fosters a culture of continuous improvement, addressing quality issues while enhancing processes and outcomes. It also emphasizes expanding knowledge related to pharmaceutical quality by staying updated with scientific advancements, regulatory changes, and industry best practices, helping organizations exceed quality expectations and leading to safer, more effective pharmaceutical products for patients.
Course Modules/Learning Objectives
- Why Q10 is Needed
- Management Responsibilities
- Continual Improvement and Lifecycle Approach
- Opportunities in Annex 1
- Elements of PQS
- Quality Management Maturity (QMM)
- Process Design and QbD Principles
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.