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Business Process Mapping – How to Prepare a Detailed System & Data Roadmap for a Clinical Trial Regulated by FDA

Business Process Mapping – How to Prepare a Detailed System & Data Roadmap for a Clinical Trial Regulated by FDA

Overview: Conducting human clinical trials requires strict adherence to government regulatory ..

Date : 30th October, 2024

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

Duration : 90 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

Scrutinizing Test Method Validation (TMV) to Verify the Performance of a Medical Device

Scrutinizing Test Method Validation (TMV) to Verify the Performance of a Medical Device

Overview: Test Method Validation (TMV) is a critical yet often misunderstood requirement in t..

Date : 21st October 2024

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

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

Best Practices in Preparation for an FDA Computer System Audit in 2024

Best Practices in Preparation for an FDA Computer System Audit in 2024

10 Minutes excerpt from the recorded event for your review: Best Practices in Preparation for a..

Date : 22nd July 2024

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

Duration : 90 Mins

The 6 Most Common Problems in FDA Software Validation and Verification in 2024

The 6 Most Common Problems in FDA Software Validation and Verification in 2024

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

Date : 18th July 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

Human Factors/ Usability Studies following ISO 62366 , the FDA Guidance and the new FDA Draft Guidance

Human Factors/ Usability Studies following ISO 62366 , the FDA Guidance and the new FDA Draft Guidance

Overview: Human Factors/Usability studies are essential in ensuring that medical devices are ..

Date : 25th June 2024

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

Duration : 75 Mins

Best Practices for Auditing a Vendor of Computer Systems Regulated by FDA

Best Practices for Auditing a Vendor of Computer Systems Regulated by FDA

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

Date : 30th May 2024

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

Duration : 90 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

GAMP®5, 2nd Edition & FDA's CSA Guidance - Aligning Validation Practices

GAMP®5, 2nd Edition & FDA's CSA Guidance - Aligning Validation Practices

Overview The landscape of computer system validation is undergoing a transformative shift wit..

Date : 30th April 2024

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

Duration : 90 Mins

Risk-Based Approach to Validating IT Infrastructure Used for FDA-Regulated Systems

Risk-Based Approach to Validating IT Infrastructure Used for FDA-Regulated Systems

Overview: For over three decades, the FDA has regulated computer system validation (CSV) acro..

Date : 25th March 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

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