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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
Nacha Rule – Third-Party Sender (TPS) Roles and Responsibilities - What to Know
Overview: In 2022, Nacha implemented significant updates to its Operating Rules to enhance cl..
Date : 20th March 2024
Time : This Event is Over and the Recorded Content is Available
Duration : 90 Mins
March 2024 Deadline: Understanding DOL's New Independent Contractor Classification Rule
Overview: The upcoming 2024 Independent Contractor Rule by the U.S. Department of Labor (DOL) ..
Date : 29th February 2024
Time : This Event is Over and the Recorded Content is Available
Duration : 90 Mins
Risk Management for ML medical devices following BS/AAMI 34971:2023 and ISO 14971
Overview: FDA has always prioritized the risk management of medical devices, adhering to its ..
Date : 27th February 2024
Time : This Event is Over and the Recorded Content is Available
Duration : 60 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FDA Recent Draft Guidance Related to 21 CFR Part 11, Electronic Records/Signatures for Clinical Investigations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
Excel Spreadsheets - Step-By-Step Instructions for Ensuring Data Integrity
Overview:The use of Excel in FDA-regulated environments extends beyond basic data organization and..
Date : 29th January 2024
Time : This Event is Over
Duration : 90 Mins
RISK MANAGEMENT FOR ML MEDICAL DEVICES FOLLOWING BS/AAMI 34971 AND ISO 14971
Overview:In the field of medical technology, the integration of Machine Learning (ML) within medic..
Date : 28th August 2023
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 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
Excel Spreadsheet in FDA Regulated Environment in 2023
Overview:The use of Excel in FDA-regulated environments goes beyond typical data organization and ..
Date : 27th July 2023
Time : This Event is Over
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
Medical Device Software Verification and Validation Following FDA 2023 Guidance and ISO 62304
Overview: In the fast-evolving field of medical technology, ensuring the safety and efficacy ..
Date : 28th May 2024
Time : 1:00 PM Eastern Time / 10:00 AM Pacific Time
Duration : 60 Mins