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Understanding and Implementing a Quality by Design Program
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Understanding and Implementing a Quality by Design Program

This training will explain the main principles behind a QbD approach and provide guidelines on how to implement the concepts into a pharmaceutical development organization.

When: Friday, May 26, 2017
1:00 PM
Where: Online
United States

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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.

Why Should You Attend:
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.

Areas Covered In This Webinar :
QbD principles discussed 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

Learning Objectives:

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 used to implement a QbD approach

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


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