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FDA Regulation of Artificial Intelligence/ Machine Learning Software following the 2025 draft Guidance
Overview: AI/ML is rapidly transforming the landscape of medicine, driving unprecedented chan..
Date : March 28, 2025
Time : This Event is Over and the Recorded Content is Available
Duration : 75 Mins
Mandatory Paid Sick Leave Breaking Through the Quagmire and Quandary of Compliance in 2025
Overview: Mandatory paid sick leave is no longer a trend—it’s becoming a nationwide standard, ..
Date : February 27, 2025
Time : This Event is Over and the Recorded Content is Available
Duration : 75 Mins
Nacha Updates in the ACH Network (Operations Bulletins – RFC and RFI Details)
Overview: The ACH Network continues to evolve, driven by technological advancements, regulato..
Date : February 26, 2025
Time : This Event is Over and the Recorded Content is Available
Duration : 90 Mins
Best Practices for Creating a Clear-Cut Contract and Service Level Agreement (SLA) with a Vendor of Computer Systems Regulated by FDA
Overview: Selecting and managing a vendor for computer systems in FDA-regulated environments ..
Date : February 26, 2025
Time : This Event is Over and the Recorded Content is Available
Duration : 90 Mins
US FDA Requirements for Medical Products Labeling / UDI
Overview: The world of medical product labeling in the United States is governed by a complex ..
Date : 10th February 2025
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
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
Navigating the New Exempt Employee Salary Thresholds: What You Need to Know
Overview:The Department of Labor's proposal to significantly raise the minimum salary threshold for..
Date : 21st February 2024
Time : This Event is Over and the Recorded Content is Available
Duration : 90 Mins
Payroll Documentation and How to Build a Good SOP
Overview: In an era where streamlined processes and strategic foresight are paramount, this w..
Date : 02nd February 2024
Time : This Event is Over and the Recorded Content is Available
Duration : 75 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 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
How to get a 510(k) for a Machine Learning Product - Understanding the Regulatory Requirements
Overview:FDA clears the final validated version of software and requires a new 510(k) submission i..
Date : 22nd February 2023
Time : This Event is Over and the Recorded Content is Available
Duration : 75 Mins