Implementing a Quality by Design Program for Drug Product Development

Overview:

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 you should 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

Areas Covered in the Session:

• 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

Who Will Benefit:

This course is designed for people tasked with developing, filing, and manufacturing pharmaceutical products especially small molecule oral dosage forms. This includes individuals that have responsibilities for formulation development, scale-up, filing, and commercial manufacture of dosage forms as well as maintaining the high quality of those products. Following personnel will benefit from the course:

• 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