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Live Webinar on Understanding and Implementing a Quality by Design Program
Presented By Training Doyens
Wednesday, February 27th at 1:00pm EST
Online sale ends: 02/27/19 at 1:00pm EST
26468 E Walker Dr, Aurora, Colorado 80016
Aurora, CO 80016-6104
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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.


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.

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.


  • 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.


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


For more detail please click on this below link:




Email: support@trainingdoyens.com

Toll Free: +1-888-300-8494

Tel: +1-720-996-1616

Fax: +1-888-909-1882


Presented By

1:00pm to 2:00pm
Doors open at 1:00pm

Live Webinar: $189.00
Recorded Webinar: $219.00

26468 E Walker Dr, Aurora, Colorado 80016<br> https://bit.ly/2QZf7Zb<br> Aurora, 80016-6104



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