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 :
QbD principles discussed in this training include:
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 Should Attend:
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. A must attend webinar for:
Quality Departments
Regulatory Departments
Compliance Departments
Production Departments
Manufacturing Departments
Engineering Departments
Process Owners
Quality Auditors
Development Departments