Quality by Design Training Course in Sofia

As part of your Quality by Design training in Sofia, you will receive:

• Hard copy/soft copy of the course material
• Quality by Design Syllabus

At Invensis, we provide Quality by Design Certification training in Sofia in different learning modes such as instructor-led classroom training, instructor-led online training, on-site group training, and focused 1 to 1 training.

No, there is no examination for Quality by Design Certification course in Sofia. This Quality by Design course provides only a basic understanding of Quality by Design concepts and techniques. If you are looking at Quality by Design certification courses in, then we offer Six Sigma Green belt, Yellow belt and Black belt training in Sofia.

Individuals and Enterprises can make payment for the training through 2 different modes such as –

• Request for Invoice
• Wire Transfer

For more information on payment details, please contact us at support@invensislearning.com

Please call us, join our Live Chat for instant support, or Request a Call Back to have your query resolved.

The course structure or outline of the instructor-led Quality by Design training program in Sofia is as follows:

• 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

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 in Sofia. The Quality by Design course in Sofia 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 in Sofia, 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 in Sofia.

The course structure or outline of the instructor-led Quality by Design training program in Sofia is as follows:

• 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