COURSE ID 2578

The QbD Toolbox: Resources That Help New QbD Programs

AVAILABLE On-demand
90 Minutes

On-Demand

Offering Price
$ 295
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Team Training

When you need on-site attention, we’re not just here to help, we’re there to help—right by your side.

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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Remember – at checkout you can choose to take this course On-demand. We offer a 10% group discount when you register 2 of more attendees (up to 10). Contact us for larger groups.

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 a proper understanding of how to establish QbD, your efforts may fail.

This 90-minute 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.

Can’t Make this LIVE Webinar?
Simply select the On Demand option when registering and we will send you access to the recorded version for 30 days. On Demand available within 3 business days after the live offering.

Our LIVE online training offers interactive participation. We highly encourage you to open your microphone and/or webcam during the live course to allow for the free exchange of remarks and questions between attendees and the course director.

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
– 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
Ranjit Barshikarhas 51 years of Pharmaceutical / Biotechnology Industry Experience in Quality, R&D, Mfg., and Regulatory. He is experienced in Quality Systems, Manufacturing Excellence, and the US and Foreign GMP Compliance. He being a QbD expert, has trained more than 1500 Scientists from Global Multinational & Generic Cos., on QbD implementation & ANDA filings for QbD elements. He has significant experience in Compliance and Quality Management, Validation, and GMP compliance auditing of manufacturing facilities for the production of sterile products by aseptic processing, solid dosage forms, etc. Additionally, Mr. Ranjit has high experience in ICH Q11-QbD implementation in API development, ICH Q14-Analytical Method Development by QbD & Validation, ICH Q12- Life Cycle Management. He has several articles published Globally on cGMP Compliances / QbD implementation. Mr. Ranjit is specialized in Process Analytical Technology (PAT) Process monitoring.