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

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

Overview: FDA has substantial authority to oversee regulated companies and their operations.&n..

Date : 30th November 2022

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

Duration : 90 Mins

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

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

Level:- Beginner to Intermediate Overview: Preparing a submission to get FDA approval for ..

Date : 22nd November 2022

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

Duration : 75 Mins

Clinical Trial Master File (TMF) and electronic Clinical Trial Master File (eTMF) and FDA Compliance

Clinical Trial Master File (TMF) and electronic Clinical Trial Master File (eTMF) and FDA Compliance

Overview: Companies engaged in the conduct of human clinical trials must adhere to specific g..

Date : 28th October 2022

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

Duration : 90 Mins

Medical Device Software Validation Meeting FDA Regulations

Medical Device Software Validation Meeting FDA Regulations

Overview: Testing software to prove that it works and has no bugs is not sufficient to obtain ..

Date : 25th October 2022

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

Duration : 75 Mins

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

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

Overview: Human Factors/ Usability is the analysis of how people interact with medical devices...

Date : 23rd September 2022

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

Duration : 60 Mins

Pharma 4.0 - Overcoming Data Integrity Issues in the Cloud to Meet FDA Compliance Requirements

Pharma 4.0 - Overcoming Data Integrity Issues in the Cloud to Meet FDA Compliance Requirements

Overview: Computer system validation has been regulated by FDA for more than 30 years, as it ..

Date : 31st August 2022

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

Duration : 1 Hour 40 Mins

Functional and System Requirements for Systems Regulated by FDA

Functional and System Requirements for Systems Regulated by FDA

Overview:Computer System Validation (CSV) has been regulated by FDA for more than 35 years, as it re..

Date : 27th July 2022

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

Duration : 1 Hour 40 Mins

The 6 Most Common Problems in FDA Software Validation and Verification - What to Know?

The 6 Most Common Problems in FDA Software Validation and Verification - What to Know?

Overview:This webinar describes the validation planning process with particular emphasis on avoidin..

Date : 14th July 2022

Time : This Event is Over

Duration : 90 Mins

Best Practices in Preparation for an FDA Computer System Audit

Best Practices in Preparation for an FDA Computer System Audit

Overview: FDA requires that all computer systems used to produce, manage and report on “GxP” (G..

Date : 23rd June 2022

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

Duration : 90 Mins

FDA Technology Modernization Action Plan and Impact on Regulated Computer Systems

FDA Technology Modernization Action Plan and Impact on Regulated Computer Systems

Overview: Computer system validation has been regulated by FDA for more than 30 years, as it re..

Date : 31st May 2022

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

Duration : 1 Hour 30 Mins

FDA Regulation of Artificial Intelligence/ Machine Learning

FDA Regulation of Artificial Intelligence/ Machine Learning

Overview: AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible ..

Date : 25th May 2022

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

Duration : 75 Mins

Preparing for an FDA Audit? Learn the Best Behavior Practices and the Do’s and Don’ts

Preparing for an FDA Audit? Learn the Best Behavior Practices and the Do’s and Don’ts

Overview: This webinar will begin by discussing and emphasizing the importance of truthfulness..

Date : 20th May 2022

Time : This Event is Over

Duration : 75 Mins

Functional and System Requirements for Systems Regulated by FDA

Functional and System Requirements for Systems Regulated by FDA

Overview:Computer System Validation (CSV) has been regulated by FDA for more than 35 years, as it r..

Date : 26th January 2022

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

Duration : 1 Hour 50 Mins

FDA Compliance and Mobile Applications - What do you need to know?

FDA Compliance and Mobile Applications - What do you need to know?

Overview:This topic is focused on the use of mobile applications to process data regulated by FDA.&..

Date : 29th November 2021

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

Duration : 1 Hour 33 Mins

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

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

Overview: Human Factors/ Usability is the analysis of how people interact with medical devices..

Date : 28th October 2021

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

Duration : 1 Hour 15 Mins

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