Live Webinar on Understanding and Implementing a Quality by Design Program
26468 E Walker Dr, Aurora, Colorado 80016-6104
26468 E Walker Dr, Aurora, Colorado 80016-6104 Aurora, CO 80016
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Start: Wednesday, February 27, 2019 1:00 PM
End: Wednesday, February 27, 2019 2:00 PM
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Event Features: Business-Related
Neighborhood: Avenue of the Arts
OVERVIEW The benefits of applying the quality by design in pharmaceutical development 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
However, implementing these principles into the pharmaceutical development culture can be challenging.
QbDin pharmaceuticals involves a complex set of interactions, technologies and systems that are not easy to grasp. 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.
• 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
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.
WHO WILL BENEFIT
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
For more detail please click on this below link:
Toll Free: +1-888-300-8494
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