San Francisco, California
London, United Kingdom
This seminar 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.
To aid the learning process, the principles of QbD will be applied to a specific program, implementation of the new Elemental Impurity guidelines, ICH Q3D. Practical implementation of ICH Q3D requires a risk based approach, but the fundamental challenge is to find a means to categorize risk. This means an exhaustive assessment of all the components of manufacturing including API, excipients, water, manufacturing equipment, processing aids, and container closure system to determine their contributions to all elemental impurities. Alternatively, it is possible to simply do final product testing on finished dosage forms. This carries the risk, however, that failure here involves discarding the batch.
Upon completing this course participants should:
- Understand the principles behind using QbD to develop a pharmaceutical product including
- 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 the important tools used to implement a QbD approach
- Understand how to utilize a risk-based approach to address implementation of elemental impurities requirements
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 managers
- Manufacturing engineers
- Production engineers
- Process owners
- Quality engineers
- Quality auditors
- Development professionals
- Senior development managers
Note: Use coupon code NB5SQH8N and get 10% off on registration.
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When & Where
Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.
Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.
Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.
Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.