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Best Practices for Responding to a Form 483 Citation and/or Warning Letter Issued by FDA in 2025

Best Practices for Responding to a Form 483 Citation and/or Warning Letter Issued by FDA in 2025

Overview: The U.S. Food and Drug Administration (FDA) plays a critical role in safeguarding pub..

Date : 27th June 2025

Time : This Event is Over and the Recorded Content is Available

Duration : 90 Mins

Data Integrity and Data Governance for Computer Systems Regulated by FDA in 2025

Data Integrity and Data Governance for Computer Systems Regulated by FDA in 2025

Overview: As regulatory scrutiny intensifies, data integrity and governance have become corne..

Date : 30th May 2025

Time : This Event is Over and the Recorded Content is Available

Duration : 75 Mins

Sampling Plans for Verification and Validation, Production Process Validation and Production Control

Sampling Plans for Verification and Validation, Production Process Validation and Production Control

Overview: When design flaws go unnoticed until late in production—or when a batch fails inspe..

Date : 23rd May 2025

Time : This Event is Over and the Recorded Content is Available

Duration : 60 Mins

US FDA Requirements for Medical Products Labeling / UDI

US FDA Requirements for Medical Products Labeling / UDI

Overview: The world of medical product labeling in the United States is governed by a complex ..

Date : 10th February 2025

Time : This Event is Over and the Recorded Content is Available

Duration : 90 Mins

Best Practices for Responding to a Form 483 Citation and/or Warning Letter Issued by FDA in 2024

Best Practices for Responding to a Form 483 Citation and/or Warning Letter Issued by FDA in 2024

Overview: The U.S. Food and Drug Administration (FDA) plays a critical role in safeguarding p..

Date : 30th August 2024

Time : This Event is Over and the Recorded Content is Available

Duration : 90 Mins

Validation of FDA-Regulated Systems with AI, ML & LLMs (ChatGPT)

Validation of FDA-Regulated Systems with AI, ML & LLMs (ChatGPT)

Overview: Life science industries — including pharmaceutical, medical device, biotechnology, ..

Date : 11th September 2025

Time : 1:00 PM Eastern Time / 10:00 AM Pacific Time

Duration : 90 Mins

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