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Data Integrity and Privacy - Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR-

Data Integrity and Privacy - Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR-

Overview: In today's rapidly evolving life sciences landscape, ensuring data integrity and pr..

Date : 21st March 2024

Time : This Event is Over

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

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

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

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

Data Integrity and Privacy: Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR -

Data Integrity and Privacy: Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR -

Overview: In today's digital age, where data integrity and privacy are more critical than eve..

Date : 12th October 2023

Time : This Event is Over

Duration : 90 Mins

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 an..

Date : 28th September 2023

Time : This Event is Over

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

Best Practices in Preparation for an FDA Computer System Audit in 2023

Best Practices in Preparation for an FDA Computer System Audit in 2023

Overview:FDA requires that all computer systems used to produce, manage and report on “GxP” (GMP, ..

Date : 18th August 2023

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

Duration : 90 Mins

Data Integrity and Privacy: Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR - What to Know

Data Integrity and Privacy: Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR - What to Know

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

Date : 22nd June 2023

Time : This Event is Over

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

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

Cybersecurity for medical devices and the US FDA Compliance - What You Need to know

Cybersecurity for medical devices and the US FDA Compliance - What You Need to know

Overview:This webinar will focus on cybersecurity of medical devices, a key concern for those who ..

Date : 23rd February 2021

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

Duration : 1 Hour 37 Mins

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