Upcoming Webinars

SQA periodically organizes webinars for its members on a variety of regulatory quality assurance topics. Webinars often are free for SQA members. Occasionally, a webinar is offered for both members and non-members.
 

Wednesday, 26 June 2019, 1:00-2:00 PM EDT

NCCSQA Chapter Series Webinar: Quality by Design: Applying Clinical Trial Principles to Preclinical Studies

Presented by: Jennifer Stanislawski, Atlantic Research Group, Inc.

In 2015, the Clinical Trials Transformation Initiative (CTTI), in order to increase the quality and efficiency in clinical trials, put forth recommended principles and tools that they called Quality by Design (QbD). The intent of QbD was to understand what data and processes lend to a successful trial by identifying and managing important and likely risks upfront in order to improve the quality and outcomes for clinical trials. In this presentation, the audience will learn the history behind and what QbD is about, a real life example of how the concept is being used, and how it can be translated and applied to GLP.

RQAP re-registration units: 0.25 GCP or GLP

Register

Date and time TBD 

EU Pharmacovigilance System Master File (PSMF): What is it?

Presented by: Andrea Stark

This is an introductory session to the EU PSMF which will cover the Regulatory basis of the PSMF, its purpose, how it is maintained and revised, what information is included in the PSMF, some examples of how companies manage it and then any trends.

RQAP re-registration units: 0.25 GCP/non-GLP

Registration coming soon.

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Use the Webinar Request Form! The form is for SQA Committees, Specialty Sections, Regional Chapters, or members. Webinar presentations should generally be offered to all SQA members (rather than just a Committee or Specialty Section). Webinars must be approved by the SQA Education Committee before they are scheduled.

Webinar Request Form