Webinar Recordings Library

Webinar recordings and PDF slides are FREE for SQA members. However, they must be "purchased" for $0.00 to add them to your "My SQA Online Education" button on your My SQA page. (You must log in to access this page.)

Recordings and PDF slides may be purchased by non-members for a small fee. Follow the links on the webinar titles below to see more details and purchase the webinar. More links will be added as recordings become available online.

Webinars by Year

Tuesday, 17 September 2019 , 12:00 - 1:00 PM EDT

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

Presented by: Andrea Stark and Karen Ward

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

Thursday, 5 September 2019 ,11:00 AM - 12:00 PM EDT

SRCSQA Chapter Series Webinar: Using File Analysis to Support Records Management Activities 

Presented by: Joseph Whittemore, Pfizer

A case study on the use of machine learning to provide insight on archived electronic records in support of records management activities.

RQAP re-registration units: 0.25 GCP or GLP

Thursday, 18 July 2019, 10:00-11:00 AM EDT

MWSQA Chapter Series Webinar: Sponsor Oversight in Clinical Trials of IMP

Presented by: Mandy Budwal-Jagait, GCP Inspector, MHRA

Requirements for sponsor oversight in regards to UK and EU regulations. Reference will also be made to ICH GCP guideline requirements with examples provided of inspection findings.

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

Recording not released; slides will be posted soon.

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

Tuesday, 26 February 2019, 1:00 PM-2:00 PM EST

Electronic Data Capture and Submissions to CVM

Presented by: Damon Bradley

CVM requires raw data be submitted to support studies.  Animal health companies continue to adopt electronic data capture systems in place of traditional use of paper forms.  This webinar will address key points in identifying raw data as collected in electronic data capture systems, data management, and preparation of data for submission to CVM.

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

Wednesday, 30 January 2019, 12:00 PM-1:00 PM EST

Effective Remote Auditing

Presented by: Larry Thomas

Audits are a principle element of a quality management system and support regulatory compliance and effectiveness.  These assessments commonly are done on-site; however, for a variety of reasons it may be preferable to conduct audits remotely. 

In this webinar we will explore the application of remote audits and how to conduct them effectively. Although the experiences will be centered around PV audits, the general concepts of remote auditing may be applied to various areas (GLP, GCP, GMP, GVP, IT, vendor, etc.). The speaker will review the key aspects of remote audits -- planning, preparation, conduct, and reporting.  Also, best practices and tips will be highlighted.  Attendees will take away practical information to improve remote audits and enhance their quality system.

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

Thursday, 17 January 2019, 12:00 PM-1:00 PM EST

Pharmacovigilance for Non-PV QA

Presented by: Sarah Mills

This training covers basic aspects of PV and intends to cover certain concepts at a high-level.

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

Thursday, 10 January 2019, 12:00-1:00 PM EST

NCARSQA Chapter Series Webinar: The Role of Metadata and Audit Trails in Ensuring Data Integrity

Presented by:  Matt Hansen

This webinar will describe how audit trails and other metadata are critical to data integrity. During the session, the presenter will explore different risks and scenarios. Audit trails and other metadata are rightfully given significant attention in regards to their ability to explain data and support its integrity. These records are generated by computerized systems and tell the story about how the data was collected and used. However, systems used in GxP-regulated activities generate audit trails that span the spectrum in regards to their content, organization, and usefulness. They can range from meeting the bare minimum of regulatory requirements (or maybe less) to recording nearly every keystroke.

RQAP re-registration units: 0.25 GCP or GLP

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