Search

Products meeting the search criteria

Functional and System Requirements for Systems Regulated by FDA - New Updates Included

Functional and System Requirements for Systems Regulated by FDA - New Updates Included

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

Date : 28th June 2023

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

Duration : 90 Mins

Medical Device Cybersecurity following 2022 FDA Premarket Guidance

Medical Device Cybersecurity following 2022 FDA Premarket Guidance

Overview: In this informative webinar, we delve into the critical field of medical device cyb..

Date : 20th June 2023

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

Duration : 60 Mins

Mastering Mobile App Validation in FDA-Regulated Environments

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

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

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

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

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

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

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

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

Showing 16 to 30 of 47 (4 Pages)