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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

Data Integrity and Privacy - Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR in 2025

Data Integrity and Privacy - Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR in 2025

Overview: In today's rapidly evolving life sciences landscape, ensuring data integrity and priv..

Date : 14th February 2025

Time : This Event is Over

Duration : 90 Mins

Validation of FDA-Regulated Systems that Incorporate Artificial Intelligence (AI) and Machine Learning (ML)-

Validation of FDA-Regulated Systems that Incorporate Artificial Intelligence (AI) and Machine Learning (ML)-

Overview: As the life sciences industry, encompassing pharmaceuticals, medical devices, biotech..

Date : 13th January 2025

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

Duration : 90 Mins + Q&A

Excel Spreadsheet in FDA Regulated Environment - Ensuring Data Integrity and 21 CFR Part 11 Compliance

Excel Spreadsheet in FDA Regulated Environment - Ensuring Data Integrity and 21 CFR Part 11 Compliance

Overview:The use of Excel in FDA-regulated environments extends beyond basic data organization and a..

Date : 19th November 2024

Time : This Event is Over

Duration : 75 Mins

Mastering Mobile App & Medical Device Software Validation and Cybersecurity in FDA-Regulated Environments

Mastering Mobile App & Medical Device Software Validation and Cybersecurity in FDA-Regulated Environments

10 Minutes excerpt from the recorded event for your review: Read the LinkedIn Article: Lin..

Date : 28th June 2024

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

Duration : 90 Mins

Data Integrity and Privacy - Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR-

Data Integrity and Privacy - Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR-

Overview: In today's rapidly evolving life sciences landscape, ensuring data integrity and pr..

Date : 21st March 2024

Time : This Event is Over

Duration : 90 Mins

Data Integrity and Privacy Compliance: 21 CFR Part 11, SaaS/Cloud, and EU GDPR for Life Sciences

Data Integrity and Privacy Compliance: 21 CFR Part 11, SaaS/Cloud, and EU GDPR for Life Sciences

Overview: In today's rapidly evolving life sciences landscape, ensuring data integrity and pr..

Date : 15th July 2025

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

Duration : 75 Mins

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