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Risk-Based Approach to Validating IT Infrastructure Used for FDA-Regulated Systems

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

Nacha Rule – Third-Party Sender (TPS) Roles and Responsibilities - What to Know

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

Risk Management for ML medical devices following BS/AAMI 34971:2023 and ISO 14971

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

How to Conduct an ACH Risk Assessment and Develop an Effective Risk Management Program

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

Medical Device Cybersecurity following September 2023 FDA Premarket Guidance

Medical Device Cybersecurity following September 2023 FDA Premarket Guidance

Overview: This webinar will cover FDA's evolving position on medical device cybersecurity. The..

Date : 29th November 2023

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

Duration : 75 Mins

FDA Technology Modernization Action Plan (TMAP) and Impact on Regulated Computer Systems and Data Integrity

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

Annual ACH Rules Compliance Audit Webinar: Navigating New Regulations

Annual ACH Rules Compliance Audit Webinar: Navigating New Regulations

Overview: Keeping up with annual ACH Rules Compliance Audits is mandatory for various financia..

Date : 16th November 2023

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

How to Conduct an ACH Risk Assessment and Develop an Effective Risk Management Program

Overview:Whether you're a Financial Institution, Third-Party Service Provider (TPSP), or Third-Par..

Date : 27th September 2023

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

Duration : 90 Mins

RISK MANAGEMENT FOR ML MEDICAL DEVICES FOLLOWING BS/AAMI  34971 AND ISO 14971

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

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

How to Conduct an ACH Risk Assessment and Develop an Effective Risk Management Program

How to Conduct an ACH Risk Assessment and Develop an Effective Risk Management Program

Overview: As a Financial Institution, a Third-Party Service Provider (TPSP) or a Third-Party ..

Date : 16th March 2023

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

Duration : 90 Mins

Computer Software Assurance: Risk-Based Validation With Time-Saving Templates

Computer Software Assurance: Risk-Based Validation With Time-Saving Templates

Overview:This webinar describes exactly what is required for compliance with Part 11 and the Europe..

Date : 30th January 2023

Time : This Event is Over

Duration : 90 Mins

Risk-based Design Control - The New Paradigm for Medical Device Design

Risk-based Design Control - The New Paradigm for Medical Device Design

Overview: Risk management overarches projects associated with a particular product family, giv..

Date : 17th February 2022

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

Duration : 1 Hour 10 Mins

Risk Management for Medical Devices per ISO 14971:2019

Risk Management for Medical Devices per ISO 14971:2019

Overview: Risk management overarches projects associated with a particular product family, gi..

Date : 11th August 2021

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

Duration : 1 Hour 19 Mins

BSA/AML Contextual Awareness - Identifying and monitoring high-risk customers

BSA/AML Contextual Awareness - Identifying and monitoring high-risk customers

Overview:   High-risk customer reviews have been a requirement since the first FFIEC Exa..

Date : 25th May 2021

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

Duration : 60 Mins

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