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Mastering Mobile App Validation in FDA-Regulated Environments
Overview: In this webinar, we will delve into the critical aspects of applying computer syste..
Date : 26th May 2023
Time : This Event is Over and the Recorded Content is Available
Duration : 90 Mins
Excel Spreadsheet in FDA Environment - Ensuring Data Integrity and 21 CFR Part 11 Compliance
Overview:Join us for an interactive webinar that demystifies the process of configuring and valida..
Date : 22nd May 2023
Time : This Event Is Over
Duration : 90 Mins
FDA Regulation of Artificial Intelligence/ Machine Learning - New FDA Guidance
Overview:Explore how AI/ML is transforming medicine by making diagnosis and treatment more accessibl..
Date : 27th April 2023
Time : This Event is Over and the Recorded Content is Available
Duration : 75 Mins
Good Documentation Practices to Support FDA Computer System Validation
Overview: Computer system validation has been regulated by FDA for more than 30 years, as it ..
Date : 29th March 2023
Time : This Event is Over and the Recorded Content is Available
Duration : 90 Mins
Excel Spreadsheets in FDA Environment - Data Integrity and 21 CFR Part 11 Compliance
Overview: This interactive webinar explains how to configure and validate a GxP compliant sprea..
Date : 27th March 2023
Time : This Event is Over
Duration : 90 Mins
Excel Spreadsheets in FDA Environment - Ensuring Data Integrity and 21 CFR Part 11 Compliance
Overview: This interactive webinar explains how to configure and validate a GxP compliant sprea..
Date : 27th February 2023
Time : This Event is Over
Duration : 90 Mins
FDA Technology Modernization Action Plan (TMAP) and Impact on Regulated Computer Systems and Data
Overview: Computer system validation has been regulated by FDA for more than 30 years, as it re..
Date : 23rd February 2023
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
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
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
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
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
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
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
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?
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