The QbD Toolbox

Resources That Help New QbD Programs

Date(s) and Time:
August 22, 2024
8 am EDT - 9:30 am EDT
Duration: 90 Minutes

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Select the on-demand option during registration, and we will automatically send you the recording when it is ready.

Course Instructor

Ranjit Barshikar

Early-Bird Offer

Limited Availability until August 9, 2024

$ 265
$ 295
Discounts: We offer a 10% group discount when you register 2 or more attendees (up to 10). Contact us for groups over 10.

Course description

View Course Outline

If you are charged with exploring or implementing a QbD effort within your organization, where do you begin? Available guidance documents do not provide all of the information necessary to effectively implement such a program. Without proper understanding of how to establish QbD, your efforts may fail.

This accredited training course presents methods that assist R&D – QbD team members and process operations personnel in understanding Product & Process. As a part of Risk Management, Risk Priority Number is an extremely useful metric for risk management only when its defining scales are appropriate. This course aids participants in establishing scales that make sense.

The course includes basic simplified factorial analysis to reduce the sheer number of experiments, multivariate data analysis and software that will perform these experiments efficiently. At its conclusion, participants will have a toolbox of options for managing the details of a QbD program.

Upon completion of this course, you will be able to:

  • Improve process and product knowledge
  • Classify ways to identify CQA, CMA & CPP
  • Develop risk analysis and management metrics, including Risk Priority Number (RPN)
  • Explain experimental design space that aid in Design of Experiments
  • Examine multivariate data using, e.g., response surfaces
  • Identify importance of control strategy

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This course is intended for professionals within the pharmaceutical industry. It will be especially valuable to personnel in the following areas: R&D, QA/QC, Regulatory, and Manufacturing.

Managers and supervisors of this personnel will also benefit from this training by learning the challenges faced by them.

Course Instructor


Ranjit Barshikar

CEO of QbD International, United Nations Adviser-Geneva

Ranjit Barshikar’s Courses


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Individual courses are remarkably effective. But sometimes when you have a specific need, it helps to have expert guidance right in the room with you and your team.

In that case, we’re happy to design a custom training for your entire team, whether online—or on-site.

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