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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
Functional and System Requirements for Systems Regulated by FDA in 2024
Overview: The validation of computer systems (CSV) under FDA regulations has shaped the way e..
Date : 25th November 2024
Time : This Event is Over and the Recorded Content is Available
Duration : 90 Mins
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
21 CFR Part 820 - Quality System Regulation - Applying Principles of Lean Documents and Lean Configuration
Overview: 21 CFR Part 820 delineates the Quality System Regulation (QSR) that governs all ent..
Date : 23rd July 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
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
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
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
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
Validation of FDA-Regulated Systems that Incorporate Artificial Intelligence (AI) and Machine Learning (ML)
Overview: As the life sciences industry, encompassing pharmaceuticals, medical devices, biote..
Date : 23rd February 2024
Time : This Event is Over and the Recorded Content is Available
Duration : 90 Mins
How to Conduct an ACH Risk Assessment and Develop an Effective Risk Management Program
Overview:In today's digital payment landscape, Financial Institutions, Third-Party Service Provide..
Date : 22nd February 2024
Time : This Event is Over and the Recorded Content is Available
Duration : 90 Mins
Best Practices in Preparation for an FDA Computer System Audit in 2023
Overview:FDA requires that all computer systems used to produce, manage and report on “GxP” (GMP, ..
Date : 18th August 2023
Time : This Event is Over and the Recorded Content is Available
Duration : 90 Mins
FDA Compliance and System Validation for Tobacco and Related Products
Overview:In this webinar, We will explore the significance of applying industry-best practices duri..
Date : 31st July 2023
Time : This Event is Over and the Recorded Content is Available
Duration : 90 Mins
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
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
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