Implementing a Quality by Design Program for Drug Product Development

The benefits of applying the QbD principles in the pharmaceutical industry have been well advertised.

Most important are the direct benefits to our primary customer, the patient. Per Janet Woodcock M.D. Director, Center for Drug Evaluation and Research (CDER), Food and Drug Administration "All products are designed and developed to be of high quality; QbD provides a structured framework for developing, documenting and presenting development rationale, experience and knowledge of the formulation and the process, and to ensure manufacture of products consistently fit for patient use." Application of these principles can also benefit the pharmaceutical companies by improving manufacturing efficiency and promoting innovation.

Why should you Attend:

• Prepare individuals to better understand the principles behind using QbD to develop a pharmaceutical product
• Understand what is meant by Quality be Design
• Understand the benefits from applying a QbD approach
• Provide key steps to implement a QbD program
• Understand what the important tools are used to implement a QbD approach

• Quality Target Product Profile (QTPP)
• Risk Assessment
• Using Models
• Design of Experiments
• Developing a Design Space
• Process Analytical Technology (PAT)
• FMEA and Control Plan
• Target Operational Profile
• Control Strategy

• Senior Quality Managers
• Quality Professionals
• Regulatory Professionals
• Compliance Professionals
• Production Supervisors
• Manufacturing Engineers
• Production Engineers
• Process Owners
• Quality Engineers
• Quality Auditors
• Development Professionals
• Senior Development Managers