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Course Descriptor

Key Topics Covered:

Who Should Attend?

Learning Outcomes

QbD is a scientific, risk-based and systematic approach to (Bio) pharmaceutical development. It is deliberate design effort from product conception through commercialization and gives compete understanding of how product attributes and process relate to product performance.

The implementation of Quality by Design (QbD) provides Cost-efficient approach to assure safe, efficient & high quality drug supply to the consumers and promises to improve manufacturing quality performance.
The regulatory authorities European Medicine Agency (EMA) and the U.S Food and Drug Administration (FDA) have also placed emphasis on QbD as a part of regulatory filling. The pharma companies applying Quality by Design (QbD) Principles for new and existing drugs are reporting considerable business benefits such as reduced operating cost, improved, more efficient manufacturing processes and better meet the regulatory expectations.

This 2-day course in QbD is designed to help delegates understand the underlying philosophies behind QbD, regulatory expectations as well as giving hands on training in the most common tools and techniques utilised in QbD.

The objective of the course is to provide scientists with the tools and understanding needed to apply QbD confidently in their projects as well as helping mangers and senior managers understand the rationale for applying QbD and overcome potential issues that personnel commonly face.

  1. The Regulatory environment of QbD
  2. What is QbD – What does Quality mean in the Pharmaceutical Industry
  3. Where to apply QbD
  4. Modern Concepts of Knowledge Management
  5. Differing types of Risk Assessments and how to carry them out
  6. Design of Experiments and Design Space
  7. The relationship between QbD and Process Validation

Scientists, Manager & Senior Managers in the pharmaceutical Industry, both in R&D and Contract Research & Manufacturing, particularly in the following areas

  1. Process Development – Drug Product
  2. Process Development – API
  3. Analytical Development
  4. Quality Assurance Personnel
  5. Quality control Personnel
  6. Design of Experiments and Design Space
  7. Regulatory affairs Personnel
  8. Process and analytical validation
  9. Tech transfer
  10. Supply Chain Personnel
  11. Manager, supervisors and Trainers involved in QbD

Upon successful completion of this course you will be able to:

  1. Understand QbD approach for Drug development & Manufacturing
  2. Understanding and application of Design of experiments (DOE)
  3. Importance of Product & Process understanding
  4. Understand the Implication of relevant EMA and FDA Guidelines
  5. Understanding of Risk management and application areas according to ICH Guidelines

 

 

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Section 1
Final Quiz