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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

Excel Spreadsheets in FDA Environment - Ensuring Data Integrity and 21 CFR Part 11 Compliance

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

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

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

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:Recent updates to the Nacha Operating Rules are further clarifying the Roles and Responsibi..

Date : 21st February 2023

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

Duration : 90 Minutes

Complying with Mandatory Paid Sick Leave vs Vacation vs PTO Laws in 2023 - What to Know

Complying with Mandatory Paid Sick Leave vs Vacation vs PTO Laws in 2023 - What to Know

Overview:Sixteen states and the District of Columbia now require employers to provide paid sick lea..

Date : 16th February 2023

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

Duration : 75 Mins

Multi-State Payroll and Telecommuting Policies - Understanding the Laws in Each State in 2023

Multi-State Payroll and Telecommuting Policies - Understanding the Laws in Each State in 2023

Overview:Understanding how manage employees in 2 or more states can be confusing.  Determinin..

Date : 10th February 2023

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

Duration : 75 Mins

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