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Recorded Webinar
Panel Discussion on Quality Management Principle in Pharmacovigilance
timelapse 60 mins with 10-15 mins of Q and A
Note:
This webinar occured in the past
Along with recorded webinar, copy of presentation slides will be shared
Recorded Webinar can be played unlimited times
Speaker/Presenter
Short Abstract
Quality Risk Management (QRM) and Quality by Design (QbD) are hot topics and many sponsors have initiated steps to implement such an approach in the manufacturing areas and now first steps are also made in the area of clinical trials. However, much less is done in terms of QRM and QbD in the area of Pharmacovigilance operations.
This seminar builds on an earlier seminar that introduced the QbD and QRM principles as well as regulatory initiatives and activities by commercial and academic stakeholders in this area.
In this seminar we start with a quick overview of the principles of QRM and QbD activities to bring all attendees “up to speed”.
The main part of this seminar will focus on practical examples on how QRM tools and approaches have been used to ensure better quality management in Pharmacovigilance operations. The concept of Key Risk Indicator (KRI) is introduced and examples of such KRIs and how they can be applied will be shared.
The seminar gives a practical demonstration on the use of QRM and KRIs to identify process weaknesses and to manage CAPAs (Corrective and Preventive Actions) with data and fact driven information.
Learning Objectives:
- The principles of QRM and QbD
- The ICH Q8, Q9 and Q10 Guidelines and how their principles can be applied to better manage Pharmacovigilance operations
- What are KRIs and how they can be defined, applied and leveraged from a Quality Management perspective
- How KRIs can be used to identify process weaknesses
- How KRIs can be used to better manage CAPAs
- The data management aspect of QRM when used in Pharmacovigilance operations
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