Quality By Design Certification Training

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Quality By Design Certification Training

Quality by Design is a systematic approach to development that starts with predefined objectives and emphasizes product and process understanding, efficient process control, and quality risk management to improve overall manufacturing quality. This Quality by Design training teaches professionals how to apply Quality by Design principles in manufacturing, resulting in lower operating costs, highly efficient manufacturing processes, and enterprises that meet changing regulatory expectations.

Wincertpro Learning’s Quality by Design (QbD) course is designed to empower professionals with the knowledge and expertise needed to implement Quality by Design principles effectively in their organizations. Our experienced instructors and seasoned practitioners in quality management provide practical insights from real-world QbD implementations. The training program comprehensively covers QbD’s end-to-end production control, streamlining product lifecycle management, continuous process improvements, and a holistic understanding of processes.

Upon completing this QbD training, professionals will have a solid grasp of Quality by Design techniques that can be readily applied. We offer flexible training options, including interactive classroom sessions, live online classes, and on-site training deliveries. Enroll today to earn your Quality by Design certification and enhance your professional capabilities.

What Will You Learn From The
Quality By Design Certification Training

Understanding the Foundations

Gain insights into the origins and the essential need for Quality by Design (QbD) principles

Aligning with Objectives

Explore the objectives of current QbD practices and how they contribute to enhanced quality and compliance

Navigating the QbD Process

Master the logic and sequential flow of the QbD development process

Proficiency in QTPPs

Develop the ability to effectively create and utilize Quality Target Product Profiles (QTPPs)

Key Features of Quality By Design Certification Training

Interactive instructor-led Quality by Design training

Highly qualified, certified, and accredited trainers

QbD course adhered to global standards

Quality by Design course completion certificate

Retake the training within the next 2 months with the Flexi Pass at no extra charge

Interaction with co-participants from diverse backgrounds

Live Virtual Instructor-led Training

Corporate
Group Training-Onsite

Syllabus

Module 1: Introduction to Quality to Design
  • Background and Drivers for QbD
  • Review of QbD Guidance Documents
  • The QbD Development Process: Flow and Logic
  • Introduction and Overview of QbD Tools
  • Risk Management in QbD
  • Design of Experiments (DoE) in QbD
  • Design Space in QbD
  • Developing Effective Control Strategie
  •  
  • Current Industry Landscape for QbD
  • Regulatory Framework and Requirements
  • Application Challenges for QbD Implementation
  •  
  • Defining Quality Target Product Profiles
  • Importance and Role of QTPP in QbD
  •  
  • Understanding CQAs, CMAs, and CPPs
  • Their Significance in QbD
  •  
  • Fundamentals of Statistical DoE
  • Practical Application of DoE in QbD
  •  
  • Concept and Significance of Design Space
  • Implementing Design Space in Process Control
  •  
  • Risk Assessment Methods
  • Managing Risks in QbD Implementation
  •  
  • Introduction to Real-time Release Testing
  • Application of RTRT in QbD
  •  
  • Real-world Case Studies in QbD
  • Practical Application and Implementation of QbD Principles
  •  

Who Should Attend Quality By Design Certification Training

Quality By Design Certification Training Eligibility

There are no pre-requisite criteria for taking the Quality by Design training. However, it would be beneficial to be familiar with the basics of quality assurance.

Exam Format

Exam Type No of Questions Exam Duration Passing Score Type
Multiple choice questions
120 questions
(100 scored, 20 unscored)
180 minutes (3 Hours)
The passing score is
determined through
psychometric analysis
Closed book

Certificate Programs

 At WinCertPro, we offer a diverse range of certificate programs tailored to meet the demands of today’s IT industry. Our programs are carefully designed to provide you with hands-on experience, industry-relevant skills, and recognized certifications, empowering you to thrive in your IT career. Our certificate programs will equip you with the expertise needed to succeed in the dynamic world of technology.

Upcoming Instructor-led Online Quality By Design Certification

Quality Function Deployment Certification

August 2025

Weekday / Weekend

Hurry Up!!! Registration closes soon! Limited Seats Left

$450.00

Quality Function Deployment Certification

September 2025

Weekday / Weekend

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$450.00

PMI-ACP Exam Prep Certification Course

October 2025

Weekday / Weekend

Hurry Up!!! Registration closes soon! Limited Seats Left

$750.00

Organize Corporate Group Quality By Design Certification Training for your teams around the world

Wincertpro learning provides In person and live virtual instructor-led corporate training program customized for enterprise teams who wish to train their employees on specific aspects of their job processes or responsibilities. The corporate training by our expert certified trainers will enhance your learning curve and enable your teams to utilize their skills to meet the industry standards.

Experienced & Industry Specific Trainers

24×7 Support

Deliver Sessions across continents via In Person/ Virtual Instructor-Led Training

Customized Trainings

 

FAQ's

  • Quality by Design certification demonstrates an individual’s understanding of the principles and best practices of Quality by Design (QbD). The certification is intended for professionals working in the pharmaceutical industry, including Quality Assurance, Quality Control, Regulatory Affairs, and Research and Development. The Quality by design course verifies that the individual has a comprehensive understanding of the concepts and principles of QbD and can apply them in developing and manufacturing pharmaceutical products. The certification is globally recognized and can help professionals to expand their career opportunities worldwide.

  • After completing your QbD training, you will gain a fundamental understanding of the following:

    • 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, and understanding design space limits
    • Development and optimization of process control strategies, which includes real-time release testing
  • The Quality by Design (QbD) examination cost is USD 445

The QbD course is not affiliated with any governing body. However, this course has been prepared by quality management experts to address the industry’s pressing need to adhere to stringent guidelines and regulatory standards worldwide

Professionals with Quality by Design Certification can pursue various career paths. They often excel in roles such as quality assurance managers, process engineers, quality control analysts, regulatory affairs specialists, and more. This certification opens doors to positions that enhance product quality, process efficiency, and regulatory compliance

The scope of Quality by Design Certification extends across diverse industries, including pharmaceuticals, biotechnology, healthcare, manufacturing, and more. It equips professionals with skills to optimize processes and product quality, making them valuable assets in any sector that prioritizes quality and efficiency

Yes, companies highly value Quality by Design Training. It demonstrates an individual’s commitment to quality improvement, process optimization, and regulatory compliance. QbD-trained professionals contribute to enhanced product quality and cost-effectiveness, which organizations highly prize in today’s competitive business landscape

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