Pharmaceutical Quality by Design

High-level overview of quality event management principles and practices. This course offers a high-level summary of quality event topics as an addition to the Quality Events SOP Guidance Documents package. Instead of detailing how to carry out each task, it highlights why these elements are vital for a complete quality system. The course covers the core principles of root cause analysis, CAPA implementation, and effective recall and complaint handling, ensuring learners grasp their importance for regulatory compliance and operational excellence. By the end, participants will understand…

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.

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…

This course will show how First Principles-based approaches will provide a valuable tool to help create such control strategies. Drawing on examples from over 30 years’ experience in the pharma industry, the attendees will see what First Principles are and how not using a First Principle approach can lead to poor problem solving and even significant disasters.

This training course is relevant to individuals working throughout the pharmaceutical product lifecycle in development, manufacturing, quality, and many other roles involved in validation of products and processes. It will help you integrate and link the science and risk-based lifecycle approach for Process Validation to your overall Pharmaceutical Quality System.

Through group exercises, this course on Quality by Design will delve into implementation and operation of an effective and efficient control strategy in manufacturing, which is a key element of process performance and product quality monitoring and continual improvement.

This interactive course will provide the learner with tools on how to implement a sustainable approach to a risk-based C&Q program, integrate the new C&Q program into existing quality systems, Quality Assurance and Engineering Management Systems and define organizational capabilities to support the new C&Q program.