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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

Validation of FDA-Regulated Systems that Incorporate Artificial Intelligence (AI) and Machine Learning (ML)

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

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

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

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FDA Recent Draft Guidance Related to 21 CFR Part 11, Electronic Records/Signatures for Clinical Investigations

FDA Recent Draft Guidance Related to 21 CFR Part 11, Electronic Records/Signatures for Clinical Investigations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

Employee Handbook Requirements for 2024. Includes Updated Federal, State and Local Regulations as well as Multi-State Regulations!

Employee Handbook Requirements for 2024. Includes Updated Federal, State and Local Regulations as well as Multi-State Regulations!

Overview: If there’s ever a time to rethink your employee handbook, it’s now. The wave of cha..

Date : 30th January 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

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

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

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

Overview:The use of Excel in FDA-regulated environments extends beyond basic data organization and a..

Date : 19th September 2024

Time : 1:00 PM Eastern Time / 10:00 AM Pacific Time

Duration : 75 Mins

Scrutinizing Test Method Validation (TMV) to Verify the Performance of a Medical Device

Scrutinizing Test Method Validation (TMV) to Verify the Performance of a Medical Device

Overview: Test Method Validation (TMV) is a critical yet often misunderstood requirement in t..

Date : 24th September 2024

Time : 1:00 PM Eastern Time / 10:00 AM Pacific Time

Duration : 90 Mins

Navigating the New DOL Rule: Independent Contractor vs Employee Classification

Navigating the New DOL Rule: Independent Contractor vs Employee Classification

Overview: The U.S. Department of Labor (DOL) has recently issued a new final rule, effective ..

Date : 25th September 2024

Time : 1:00 PM Eastern Time / 10:00 AM Pacific Time

Duration : 75 Mins

Preparing a FDA 510(k) submission - What to Know in 2024

Preparing a FDA 510(k) submission - What to Know in 2024

Overview: The FDA 510(k) submission process remains one of the most crucial regulatory pathwa..

Date : 26th September 2024

Time : 1:00 PM Eastern Time / 10:00 AM Pacific Time

Duration : 75 Mins

Business Process Mapping – How to Prepare a Detailed System & Data Roadmap for a Clinical Trial Regulated by FDA

Business Process Mapping – How to Prepare a Detailed System & Data Roadmap for a Clinical Trial Regulated by FDA

Overview: Conducting human clinical trials requires strict adherence to government regulatory ..

Date : 27th September, 2024

Time : 1:00 PM Eastern Time / 10:00 AM Pacific Time

Duration : 90 Mins

Multi-State employment - Manage Payroll for Remote & Distributed Teams

Multi-State employment - Manage Payroll for Remote & Distributed Teams

Overview: Navigating the complexities of multistate payroll tax compliance has always been a ..

Date : 07th October 2024

Time : 1:00 PM Eastern Time / 10:00 AM Pacific Time

Duration : 90 Mins

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