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Excel Spreadsheet in FDA Regulated Environment in 2023

Excel Spreadsheet in FDA Regulated Environment in 2023

Overview:The use of Excel in FDA-regulated environments goes beyond typical data organization and ..

Date : 27th July 2023

Time : This Event is Over

Duration : 90 Mins

Functional and System Requirements for Systems Regulated by FDA - New Updates Included

Functional and System Requirements for Systems Regulated by FDA - New Updates Included

Overview: Computer System Validation (CSV) has been regulated by FDA for more than 35 years, a..

Date : 28th June 2023

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

Duration : 90 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

Engineering Change Control in Medical Device Environment

Engineering Change Control in Medical Device Environment

Overview:Change control focuses on managing changes throughout a product’s life cycle as a part of ..

Date : 30th March 2023

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

Duration : 75 Mins

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

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

Preventing Human Error in the Life Sciences - Pharmaceutical and Medical Device

Preventing Human Error in the Life Sciences - Pharmaceutical and Medical Device

Overview: Human Error occurs in all settings.  In the world of pharmaceutical and medica..

Date : 29th July 2022

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

Duration : 90 Mins

Writing Effective SOPs for the Medical Device and Pharmaceutical

Writing Effective SOPs for the Medical Device and Pharmaceutical

Overview: Standard Operating Procedures (SOPs) are a critical ingredient in an effective and ef..

Date : 30th June 2022

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

Duration : 75 Mins

Preventing Medical Device Recalls – A Prevention Strategy

Preventing Medical Device Recalls – A Prevention Strategy

Overview:  In a recent study, the FDA has reported a 95% increase in medical device recalls ..

Date : 28th June 2022

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

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

Writing Effective SOPs for the Medical Device and Pharmaceutical

Writing Effective SOPs for the Medical Device and Pharmaceutical

Overview: Standard Operating Procedures (SOPs) are a critical ingredient in an effective and ..

Date : 18th November 2021

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

Duration : 1 Hour 02 Mins

FDA Regulation of Mobile medical apps and cybersecurity

FDA Regulation of Mobile medical apps and cybersecurity

Overview: This webinar will explain how to determine if your app is a medical device and if it..

Date : 24th August 2021

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

Duration : 60 Mins

Sterilization of Pharmaceutical Products and Medical Devices

Sterilization of Pharmaceutical Products and Medical Devices

Overview: This topic will discuss the methods of sterilization to be used on medical devices a..

Date : 19th August 2021

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

Duration : 60 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

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