Length: 2 Days
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Quality by Design (QbD) in Pharmaceuticals Workshop by Tonex

Certified Healthcare Systems Thinking Specialist (CHSTS™) Certification Course by Tonex

This workshop focuses on the Quality by Design (QbD) principles in pharmaceutical development, emphasizing the importance of designing quality into products from the outset. Participants will learn how to apply QbD methodologies to enhance product quality and process performance.

Learning Objectives:

  • Understand the principles and benefits of QbD in pharmaceuticals.
  • Learn to develop a QbD framework for pharmaceutical products.
  • Gain skills to design robust manufacturing processes.
  • Understand regulatory expectations for QbD implementation.
  • Develop strategies for continuous improvement in product development.
  • Learn to use QbD tools and techniques effectively.

Audience:

  • Pharmaceutical Scientists
  • Quality Assurance and Quality Control Professionals
  • Regulatory Affairs Specialists
  • Process Development Engineers
  • Manufacturing Personnel
  • R&D Teams

Program Modules:

  1. Introduction to Quality by Design (QbD)
    • Overview of QbD principles
    • Historical background and evolution of QbD
    • Key concepts and terminology
    • Regulatory guidance on QbD (ICH Q8, Q9, Q10)
    • Benefits of QbD in pharmaceutical development
    • Case studies and examples
  2. QbD Framework and Tools
    • Development of a QbD framework
    • Critical Quality Attributes (CQAs)
    • Quality Target Product Profile (QTPP)
    • Risk assessment and management tools
    • Design of Experiments (DoE)
    • Process Analytical Technology (PAT)
  3. Design Space and Control Strategy
    • Identification of design space
    • Establishing control strategies
    • Use of modeling and simulation
    • Process validation using QbD principles
    • Lifecycle management of design space
    • Continuous process verification
  4. Regulatory Expectations and Compliance
    • Regulatory expectations for QbD implementation
    • Submissions and documentation requirements
    • Interactions with regulatory agencies
    • Inspection and audit preparedness
    • Post-approval changes and QbD
    • Global regulatory perspectives
  5. QbD in Process Development
    • Application of QbD in early development
    • Scale-up and technology transfer
    • Optimization of manufacturing processes
    • Real-time release testing (RTRT)
    • Use of advanced analytics
    • Case studies in process development
  6. Continuous Improvement and Lifecycle Management
    • Continuous improvement methodologies
    • Change control management
    • Monitoring and trending quality data
    • Knowledge management and sharing
    • Lifecycle management strategies
    • Future trends in QbD

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