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Best Practices in Preparation for an FDA Computer System Audit in 2024
Overview: The FDA mandates that all computer systems used to produce, manage, and report on “..
Date : 22nd July 2024
Time : This Event is Over and the Recorded Content is Available
Duration : 90 Mins
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
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
FDA Recent Draft Guidance Related to 21 CFR Part 11, Electronic Records/Signatures for Clinical Investigations
Overview: Companies engaged in human clinical trials must comply with specific regulatory requ..
Date : 01st February 2024
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 Integrity
Overview: For over three decades, the FDA has regulated computer system validation in industr..
Date : 27th November 2023
Time : This Event is Over and the Recorded Content is Available
Duration : 90 Mins
Data Integrity and Data Governance for Computer Systems Regulated by FDA
Overview:Navigating the FDA's guidelines on computer system validation is no simple task, particul..
Date : 26th September 2023
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
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
Data Privacy: Navigating CPRA, HIPAA & GDPR Compliance Requirements for Industry
Overview: The California Privacy Rights Act (CPRA) passed by voters in 2020 came into effect ..
Date : 21st April 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