Overview:
This training will explain the main principles behind a QbD approach and provide guidelines in how to implement the concepts into a pharmaceutical development organization.
Topics covered will include the target product quality profile, risk assessment, methods to establish a design space, and design of a control strategy. This review will help bridge the gap between understanding the principles and practical application.
Why you should Attend:
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. However, implementing these principles into the pharmaceutical development culture can be challenging. QbD involves a complex set of interactions, technologies and systems that are not easy to grasp.
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:
- 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