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510K Submission Process for Medical Devices

510K Submission Process for Medical Devices

Level:- Beginner to Intermediate Overview: There are three types of 510(k) submissions t..

Date : 21st November 2022

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

Duration : 90 Mins

Clinical Trial Master File (TMF) and electronic Clinical Trial Master File (eTMF) and FDA Compliance

Clinical Trial Master File (TMF) and electronic Clinical Trial Master File (eTMF) and FDA Compliance

Overview: Companies engaged in the conduct of human clinical trials must adhere to specific g..

Date : 28th October 2022

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

Duration : 90 Mins

ABC’s of Completing the Annual ACH Rules Compliance Audit

ABC’s of Completing the Annual ACH Rules Compliance Audit

Overview: The Nacha Operating Rules and Guidelines require that all participating depository ..

Date : 27th October 2022

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

Duration : 90 Mins

Simplifying the Complexities of the  Family and Medical Leave Act

Simplifying the Complexities of the Family and Medical Leave Act

Overview: The Family and Medical Leave Act is probably THE most complex piece of federal empl..

Date : 26th October 2022

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

Duration : 75 Mins

Medical Device Software Validation Meeting FDA Regulations

Medical Device Software Validation Meeting FDA Regulations

Overview: Testing software to prove that it works and has no bugs is not sufficient to obtain ..

Date : 25th October 2022

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

Duration : 75 Mins

NEW Nacha Rule – Third-Party Sender (TPS) Roles and Responsibilities

NEW Nacha Rule – Third-Party Sender (TPS) Roles and Responsibilities

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

Date : 30th September 2022

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

Duration : 90 Mins

Unemployment Insurance – 2022 - 2023 Critical Issues

Unemployment Insurance – 2022 - 2023 Critical Issues

Overview: Unlike other human resource management issues, unemployment insurance (UI) managemen..

Date : 28th September 2022

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

Duration : 90 Mins

Data Integrity and Governance for Computer Systems Regulated by FDA

Data Integrity and Governance for Computer Systems Regulated by FDA

Overview:The Webinar will focus on the importance of ensuring that the validation of an FDA-regulate..

Date : 27th September 2022

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

Duration : 90 Mins

Multi-State Payroll Taxation - Understanding the Payroll Laws in Each State

Multi-State Payroll Taxation - Understanding the Payroll Laws in Each State

Overview: To better understand the laws in each state and the tax guidance on how to determine ..

Date : 27th September 2022

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

Duration : 60 Mins

Human Factors/ Usability Studies following ISO 62366 and the new FDA Guidance

Human Factors/ Usability Studies following ISO 62366 and the new FDA Guidance

Overview: Human Factors/ Usability is the analysis of how people interact with medical devices...

Date : 23rd September 2022

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

Duration : 60 Mins

Water Systems in Pharmaceutical Manufacturing Industry

Water Systems in Pharmaceutical Manufacturing Industry

Overview: This seminar will provide an overview of water systems used for pharmaceutical manu..

Date : 22nd September 2022

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 : 15th September 2022

Time : This Event is Over

Duration : 90 Mins

Pharma 4.0 - Overcoming Data Integrity Issues in the Cloud to Meet FDA Compliance Requirements

Pharma 4.0 - Overcoming Data Integrity Issues in the Cloud to Meet FDA Compliance Requirements

Overview: Computer system validation has been regulated by FDA for more than 30 years, as it ..

Date : 31st August 2022

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

Duration : 1 Hour 40 Mins

Mandatory Paid Sick Leave vs Vacation vs PTO: What to Know

Mandatory Paid Sick Leave vs Vacation vs PTO: What to Know

Overview: Fifteen states and the District of Columbia now require employers to provide paid sic..

Date : 30th August 2022

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

Duration : 75 Mins

Final Paycheck Requirements for Payroll Professionals - What to Know?

Final Paycheck Requirements for Payroll Professionals - What to Know?

Overview:This webinar will go into detail that employers face when paying terminated associates.&n..

Date : 24th August 2022

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

Duration : 60 Mins

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