Pharmaceutical Quality by Design

Engineering and Validation

In today’s highly competitive environment, the pharmaceutical industry is challenged with tremendous pressure to meet the highest quality of drug products as governed by authoritative regulatory bodies while maintaining the agility to be first in the market and to maximize the return on their investment.  Failure to meet such quality requirements results in a significant shift in the company market share.

Quality by Design (QbD) is a new approach to a quality system based on understanding that quality is built into a product not tested at the end of the production line “Quality by Testing”.  Quality is designed at an early stage of the drug product development and throughout a product’s life cycle.

In 2002, United States Food and Drug Administration (USFDA) made the first step towards integrating the QbD concept into current Good Manufacturing Practices (cGMPs), and in 2004 USFDA released its final report on ‘Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach’ guideline, with the aim of modernizing the regulation of pharmaceutical manufacturing and product quality.

3 days (2 days can be customized)
Course fee

Program Description

The course will offer an excellent introduction for those who are less familiar with QbD.  Pharmaceutical professionals with more experience with QbD will further develop new ideas on how to further implement the company's QbD program. This interactive training workshop utilizes the official Product Quality Lifecycle Implementation (PQLI) Guides published by the International Society for Pharmaceutical Engineering (ISPE), the International Conference on Harmonization (ICH), World Health Organization (WHO), and other international and regional agencies. Example to explain how products and processes can be developed, and how they relate to current manufacturing practices, will be provided.  Furthermore, exercises will be presented to demonstrate the implementation of an effective and efficient control strategy in manufacturing to monitor the process performance, product quality, and continual improvement.

Target Level

  • Research and Development
  • Manufacturing Managers and Supervisors
  • Engineering
  • Quality Assurance
  • Process Scale-Up and Technology Transfer
  • Process Validation
  • Regulatory Affairs


1.Regulatory background and benefits of QbD 2.Elements of Pharmaceutical Development

  1. Quality Target Product Profile
  2. Critical Quality Attributes
  3. Risk Assessment
  4. Design Space
  5. Control Strategy
  6. Product Lifecycle Management
  1. Quality Risk Management (QRM)
  2. Quality Risk Management Process
  3. Risk Management Methodology
  4. Risk Management Method and Tools
  5. Application of QRM
  6. Illustrative Exercise
  7. Pharmaceutical Quality System (PQS)
  8. Management System
  9. Management Responsibility
  10. Continual Improvement of Product Quality and Process Performance
  11. Corrective Action / Preventive Action (CAPA)
  12. PQS/GMP and Relationship to Control Strategy
  1. Process Validation: General Principles and Practices; US FDA Guidance for Industry
  1. Process Validation Stages
  2. Control Strategy – Process Analytical Technology (PAT)
  3. Continuous Improvement (CI)
  4. Introduction to Statistical Process Control

Objectives and Expected Results

Knowledge Acquired by Attending

  • Understand and apply the QbD principles of a Science- and Risk-Based approach to pharmaceutical development.
  • The importance of product and process understanding and patient requirements.
  • Demonstrate basic knowledge about the relationship of the QbD approach into design space and further into the regulatory framework.
  • Understand the application of Quality Risk Management (QRM) and how to use some QRM tools (Ishikawa Diagram, FMEA, Risk Ranking) in risk assessment.
  • Understand the relationship between PQS and GMP and how they link to Control Strategy.
  • Understand the new requirements for Process Validation.
  • Have the opportunity to understand the statistical tools and methodologies used in product and process development and process continuous monitoring and improvement.

Others Training Materials

Target group

  • -

    Trainer Languages English/Arabic

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Interested in signing up a group of people for this course?

Please contact our Business Development team:
[email protected]
00962 798756232