SQA Learning Foundation

08/28/2024

Everyone's talking about but do you know its impact on quality in ?

Find out at the "AI Unleashed ..." session at SQA's Sept. .

This video outlines the details > https://bit.ly/4dFOEee

More about the Quality College > https://bit.ly/3Wo6dJD

Join speakers Steve Thompson, Tommi Papson, and Jacqueline Bushongfor this engaging new course "AI Unleashed: Fun and Exciting Tools, Tips, Tricks, and Techn...

08/28/2024

SQA offers its members a 15% discount on major events like September's ?

Find out about membership benefits that come with a reasonable investment -- for industry professionals as well as students.

https://bit.ly/4fdVE2X

Join an association of over 2,400 QA professionals who are dedicated to implementing Good Clinical Practices (GCPs) Good Laboratory Practices (GLPs) and Good Manufacturing Practices (GMPs) in industry, government, academia and consulting. 

08/27/2024

Connect Lounge: Artificial Intelligence – Approach, Application, Acceptance - tomorrow
Sponsored by: Beyond Specialty Section (BCSS)

Presented by: Leo Schilling, Lisa Olson, Kamila Novak

This Lounge will be an open discussion and an interactive conversation about experiences, approaches, examples, and pros and cons.

Register today!
https://bit.ly/4dQPrsE

08/26/2024

Register today for discounted early registration rates for our upcoming September Quality College.

Check out courses in , Tools, techniques, and more.

Last chance to lock in your spot at a lower rate!

08/23/2024

SQA offers members a 15% discount on major events like September's .

Find out about membership benefits that come with a reasonable investment -- for industry professionals as well as students.

https://bit.ly/4fdVE2X

Join an association of over 2,400 QA professionals who are dedicated to implementing Good Clinical Practices (GCPs) Good Laboratory Practices (GLPs) and Good Manufacturing Practices (GMPs) in industry, government, academia and consulting. 

08/22/2024

Commentary piece on and -- FDA Bases Regulatory Decision on ML-Generated Data

" ... with appropriate bridging and proper validation, FDA will consider evidence facilitated by ML to be real evidence."

https://bit.ly/4dcFPIH

The U.S. Food and Drug Administration is all about hard science, and correlation of variables is not evidence of causation. To make a regulatory decision, FDA has long held that line, requiring evidence of actual occurrences — e.g., data from a clinical trial showing X number of patients experienc...

08/20/2024

Check out the many events happening for the rest of August and into September. From Happy Hours to Quality College courses, it's all here!

https://bit.ly/3RmsJxQ

For meetings of Specialty Sections, Committees, and other SQA Connect communities, please see the SQA Meeting Calendar You must be a member of a Community to access its meetings.

08/19/2024

Need Training? Working in a facility and need to brush up on GLP regulatory requirements?

Join course " Techniques," presented by Gina Tucker and Sara Rybak.

Learn more & sign up! | https://bit.ly/3ypkMmQ

08/16/2024

Pharma’s attitudes on revealed https://bit.ly/4fFGwfh

AI is generally being embraced in the pharma and life sciences, but concerns around data accuracy and transparency remain, a survey reveals.

08/15/2024

“Are you implementing in China? Are you aware that supervision of these clinical trials has changed from certification to a new process launched by their regulatory body the National Medical Product Administration (NMPA)? And that clinical trial site inspections have become common and important for NDAs in China?

If so, we suggest registering for the 's course “Inspection Management: Risk-based Clinical Trial Site Inspection by NMPA (Chinese HA).”

Attendees to the course, developed by China Quality Assurance Forum (CQAF), will hear speakers discuss:
• Key elements of the approach and procedures for NMPA site inspections.
• Their experience on current focused areas.
• How to best manage inspections and use common inspection finding metrics to help participants better plan clinical trials for in China.

Learn more about this course >> https://bit.ly/4dIUBqp

Learn about the CQAF here >> https://bit.ly/4dmRLaV

BONUS:
Watch this interview with CQAF members about what course attendees can expect >> https://bit.ly/3YMwnav

Inspection Management: Risk-based Clinical Trial Site Inspection by NMPA (Chinese HA)Since the reform of the drug and medical device review and approval syst...

08/15/2024

From -- Artificial Intelligence and Machine Learning ( / ) for Drug Development -- link to related publications

https://bit.ly/4ci3OET

Computer science, statistics & engineering uses algorithms/models to perform tasks & exhibit behaviors such as learning, making decisions, and making prediction