Enroll for Quality by Design (QbD) training course in United States from Invensis Learning. Quality by Design is a systematic approach to development that begins with predefined objectives and emphasizes understanding of the product and process, efficient process control, and quality risk management to improve the overall manufacturing quality. Implementing the Quality by Design (QbD) principles in manufacturing has resulted in reduced operating costs, highly efficient manufacturing processes and better positioning companies to meet increasing regulatory expectations.
Participants attending this Quality by Design course will learn how to prioritize process parameters for screening designs, design robust processes using statistical design of experiments (DoE), bridge the bench and the commercial design spaces using mixing and scale-up calculations, quantify process risk, select suitable process analytical technology tools (PAT) and more. Participants attending this training will receive a hard copy of the course material.
We deliver Quality by Design Training in both classroom and live online virtual modes.
This Quality by Design training is available across multiple cities in United States.
I would like to thank Invensis Learning for helping me in achieving my learning goals. The trainer was highly-qualified and helped me to understand the subject in a holistic manner. It was a seamless training experience and I highly recommend Invensis Learning for their expertise in the training and certification domain.
Key Features of Quality by Design Training
Interactive instructor-led Quality by Design training in United States- Highly qualified, certified, and accredited trainers
- Course completion certificate provided
- Get Quality by Design Study Guide created by subject matter experts
- Get to know industry best practices and case studies
Insights about Quality by Design Training Course
Implementing the Quality by Design (QbD) principles in manufacturing has resulted in reduced operating costs, highly efficient manufacturing processes and better positioning companies to meet increasing regulatory expectations. The Quality by Design course will teach participants to prioritize process parameters for screening designs, design robust processes using statistical design of experiments (DoE), bridge the bench and the commercial design spaces using mixing and scale-up calculations, quantify process risk, select suitable process analytical technology tools (PAT) and more
After completing your Quality by Design training, you will gain a basic understanding of:
- The origins and need for QbD for pharmaceutical products
- The objectives for current QbD practices
- The overall logic and flow of the QbD development process, which includes the use and application of the various tools
- Development and use of Quality Target Product Profiles (QTPPs)
- Definition and verification of Critical Quality Attributes (CQAs), Critical Material Attributes (CMAs) and Critical Process Parameters (CPPs)
- Facets of statistical design of experiments (DOEs),
- Design Space and its application in process control, lifecycle management, understanding design space limits.
- Development and optimization of process control strategies, which includes real-time release testing.
Job roles that can ideally take up Quality by Design Course, but are not limited to:
- Distribution Manager
- Production Managers
- Engineering Team
- Technical Staff
- Quality Assurance
- Regulatory and Other Management positions who are directly or indirectly involved in manufacturing processes
There are no pre-requisite criteria to take up Quality by Design Training.
Syllabus of Quality by Design Training
- Background and drivers for QbD
- QbD guidance review
- QbD development process and flow/logic
- Introduction and overview of QbD tools
- Risk management
- Design of Experiments
- Design Space
- Control Strategies
- Current industry and regulatory landscape, and application challenges for QbD
Download detailed course syllabus
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