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The 6 Most Common Problems in FDA Software Validation and Verification in 2025

The 6 Most Common Problems in FDA Software Validation and Verification in 2025

Overview: Professionals working with FDA-regulated software face numerous challenges when it co..

Date : 12th June 2025

Time : This Event is Over

Duration : 75 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

FDA Guidance for Use of Social Media by Regulated Industries

FDA Guidance for Use of Social Media by Regulated Industries

Overview: In the early days of social media, regulatory agencies were observers — watching as..

Date : 30th April 2025

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

Duration : 90 Mins

Excel Spreadsheet in FDA Regulated Environment - Ensuring Data Integrity and 21 CFR Part 11 Compliance in 2025

Excel Spreadsheet in FDA Regulated Environment - Ensuring Data Integrity and 21 CFR Part 11 Compliance in 2025

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

Date : 11th April 2025

Time : This Event is Over

Duration : 90 Mins

Effective Technical Writing for Medical Devices: Improving Your Skills for Clear and Concise Communication

Effective Technical Writing for Medical Devices: Improving Your Skills for Clear and Concise Communication

Overview: In the world of medical device manufacturing, technical writing is more than just a..

Date : 27th March 2025

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 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

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

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

Preparing a FDA 510(k) submission - What to Know in 2024

Preparing a FDA 510(k) submission - What to Know in 2024

Overview: The FDA 510(k) submission process remains one of the most crucial regulatory pathwa..

Date : 29th October 2024

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

Duration : 60 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

Medical Device Hazard analysis following ISO 14971 - Understanding The Process in Detail in 2024

Medical Device Hazard analysis following ISO 14971 - Understanding The Process in Detail in 2024

Overview: In the world of medical device development, the US FDA places a high priority on ri..

Date : 14th August 2024

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

Duration : 75 Mins

Medical Device Software Verification and Validation Following FDA 2023 Guidance and ISO 62304

Medical Device Software Verification and Validation Following FDA 2023 Guidance and ISO 62304

Overview: In the fast-evolving field of medical technology, ensuring the safety and efficacy ..

Date : 28th May 2024

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

Duration : 60 Mins

Excel Spreadsheet in FDA Environment - Ensuring Data Integrity and 21 CFR Part 11 Compliance in 2024

Excel Spreadsheet in FDA Environment - Ensuring Data Integrity and 21 CFR Part 11 Compliance in 2024

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

Date : 15th May 2024

Time : This Event is Over

Duration : 90 Mins

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