Webinars

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iQuality eQMS Webinar Series : Season 1, Episode1 3 A's of an eQMS

Pavani Madabhushi

Pavani Madabhushi

CG

Deric Glissmeyer

Deric Glissmeyer

CG

Tuesday May 18 2021 07:30 AM EST

In this webinar, we will talk about how choosing the right eQMS system is crucial for your existing process & the Top 3 elements you should keep in mind while choosing the QMS for your organization.

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CSA Revolution: Season 2, Episode 4 Transform Software Defects (J&J Case Study)

Khaled Moussally

Khaled Moussally

CG

Ron Schardong

Ron Schardong

Johnson & Johnson

Stephen Cook

Stephen Cook

CG

Thursday Apr 22 2021 07:30 AM EST

When you do your software testing, and you have a bug or defect, script error, tester error – do you treat them all the same? Should you treat them all the same?

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FDA Part Two - Data Integrity: The Challenges & CSA Application

Francisco Vicenty

Francisco Vicenty

FDA

Stephen Cook

Stephen Cook

CG

Ken Shitamoto

Ken Shitamoto

GILEAD

Khaled Moussally

Khaled Moussally

CG

Tuesday Mar 16 2021 06:30 AM EST

In part two, we learnt how CSA can be adapted to benefit your organization and the application to Data Integrity. Beyond the conversation of ALCOA and ALCOA+, the panelists discussed data integrity challenges the industry is facing and the importance of controls around application-related data followed by several of the most common FDA non-compliance findings, where the DI guidance may not have covered.

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CSA Revolution Season Two Episode 2 with FDA

Karen Takahashi (Invited)

Karen Takahashi (Invited)

FDA

Ken Shitamoto

Ken Shitamoto

GILEAD

Francisco Vicenty

Francisco Vicenty

FDA

Tuesday Jan 26 2021 07:30 AM EST

For the first time ever, hear directly from the CDER & CDRH within the FDA discussing Data Integrity Challenges and CSA Application

Watch Now

CSA Revolution: Season Two, Episode I with Data Integrity & CSA Experts

Ken Shitamoto

Ken Shitamoto

GILEAD

Shana Kinney

Shana Kinney

RGNX

Senthil Gurumoorthi

Senthil Gurumoorthi

GILEAD

Raechelle Raimondo

Raechelle Raimondo

ABBV

Wednesday Nov 18 2020 09:30 AM EST

Hear directly from the source, FDA - Industry CSA Team & Colleagues in a Panel setting discussing the upcoming ISPE GAMP Good Practice Guide (GPG) Data Integrity (DI) By Design and the CSA Appendix

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CSA Revolution Webinar Series Episode 6 w/ Lantheus & FDA

Lou Poirier

Lou Poirier

LMI

Khaled Moussally

Khaled Moussally

CG

Francisco Vicenty

Francisco Vicenty

FDA

Thursday Sep 17 2020 09:30 AM EST

Presentation Material used during this live webinar on September 17 with Lantheus Medical Imaging & the FDA discussing how to overcome Organizational Culture Barriers with CSA

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CSA Revolution Webinar Series Episode 5 w/ Boston Scientific

Khaled Moussally

Khaled Moussally

CG

Ray Murphy

Ray Murphy

BSX

Damien McPhillips

Damien McPhillips

BSX

Thursday Sep 03 2020 09:30 AM EST

“Hear directly from the source” (FDA - Industry CSA Team). On-Demand Webinar w/ Boston Scientific on their CSA journey and Case Study on PM / Calibration System.

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CSA Revolution Webinar Series Episode 4 w/ MedTronic

Stephen Cook

Stephen Cook

CG

Khaled Moussally

Khaled Moussally

CG

April Francis

April Francis

MDT

Thursday Aug 20 2020 09:30 AM EST

“Hear directly from the source” (FDA - Industry CSA Team). On-Demand Webinar w/ MedTronic on their CSA journey and how automating CSA using Siemens Polarion was such a success!

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CSA Revolution Webinar Series Episode 3 w/ Fresenius, FDA & Siemens

Jason Spiegler

Jason Spiegler

Siemens

Marc Kotter

Marc Kotter

FMC

Bill D’Innocenzo

Bill D’Innocenzo

FMC

Francisco Vicenty

Francisco Vicenty

FDA

Thursday Aug 06 2020 09:30 AM EST

“Hear directly from the source” (FDA - Industry CSA Team). On-Demand Webinar w/ Fresenius, FDA & Siemens on Fresenius CSA journey.

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CSA Revolution Webinar Series Episode 2 w/ Johnson & Johnson

Ron Schardong

Ron Schardong

Johnson & Johnson

Melissa Vazquez

Melissa Vazquez

Johnson & Johnson

Khaled Moussally

Khaled Moussally

CG

Thursday Jul 23 2020 09:30 AM EST

“Hear directly from the source” (FDA - Industry CSA Team). On-Demand Webinar w/ Johnson & Johnson on the results of their CSA Case Study on MES.

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CSA Revolution Webinar Series Kickoff w/ the FDA

Francisco Vicenty

Francisco Vicenty

FDA

Khaled Moussally

Khaled Moussally

CG

Stephen Cook

Stephen Cook

CG

Thursday Jul 16 2020 09:30 AM EST

“Hear directly from the source” (FDA - Industry CSA Team). On-Demand Webinar w/ the FDA’s Francisco Vicenty discussing the cultural barriers paralyzing the life science industry, the upcoming FDA draft guidance on CSA and the draft guidance’s alignment to ISPE GAMP.

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CSA Revolution Webinar Series Episode 1 w/ Gilead Life Sciences

Khaled Moussally

Khaled Moussally

CG

Senthil Gurumoorthi

Senthil Gurumoorthi

GILEAD

Ken Shitamoto

Ken Shitamoto

GILEAD

Thursday Jul 09 2020 09:30 AM EST

“Hear directly from the source” (FDA - Industry CSA Team). On-Demand Webinar w/ Gilead Life Sciences on their CSA journey, challenges and successes.

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Everything about FDA's draft guidance on Computer Software Assurance (CSA)

Wednesday Mar 11 2020 12:31 PM EST

Hear directly from members of this FDA-Industry team on how to shift from a burdensome, documentation-heavy CSV approach to a streamlined CSA approach using the upcoming FDA’s new draft guidance.

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Panel discussion with the FDA on “The Future of Quality Management and FDA Case for Quality initiatives”

Thursday Feb 27 2020 12:30 PM EST

Watch this killer panel “FDA’s Francisco Vicenty, Artificial Intelligence Industry Leader Chakri Uddaraju, Quality Industry Leaders Larry Mager & Khaled Moussally” discussion on the future of Quality Management and why the future is now.

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What is changing at the FDA in terms of Quality vs Compliance?

Tuesday Feb 18 2020 12:28 PM EST

Watch the FDA’s Case for Quality Program Manager explain why good Quality practices automatically result in Compliance and how FDA is driving this paradigm shift through it’s industry collaboration initiatives.

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Q & A session with the FDA on FDA’s draft guidance Computer Software Assurance (CSA)

Thursday Feb 13 2020 12:29 PM EST

Watch this recorded Webinar with the FDA and industry practitioners on FDA’s upcoming draft guidance on CSA. Expect all the common questions to be answered in this webinar including “Are inspectors going to be okay with CSA practices ?

Watch Now

What is the difference between Quality Management System (QMS) and Quality System Management (QSM)? How can AI help build better quality products?

Thursday Feb 06 2020 12:27 PM EST

How is QMS different to QSM? How both are essential to drive the quality of products? How can AI help drive better product quality in the medical device industry?

Watch Now

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