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Data Integrity and Data Governance for Computer Systems Regulated by FDA in 2025
Overview: As regulatory scrutiny intensifies, data integrity and governance have become corne..
Date : 30th May 2025
Time : This Event is Over and the Recorded Content is Available
Duration : 75 Mins
Validation of FDA-Regulated Systems that Incorporate Artificial Intelligence (AI) and Machine Learning (ML)-
Overview: As the life sciences industry, encompassing pharmaceuticals, medical devices, biotech..
Date : 13th January 2025
Time : This Event is Over and the Recorded Content is Available
Duration : 90 Mins + Q&A
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 : 29th October 2024
Time : This Event is Over and the Recorded Content is Available
Duration : 60 Mins
Mastering Mobile App & Medical Device Software Validation and Cybersecurity in FDA-Regulated Environments
10 Minutes excerpt from the recorded event for your review: Read the LinkedIn Article: Lin..
Date : 28th June 2024
Time : This Event is Over and the Recorded Content is Available
Duration : 90 Mins
Best Practices for Auditing a Vendor of Computer Systems Regulated by FDA
10 Minutes excerpt from the recorded event for your review:Read the LinkedIn Article: LinkedIn ..
Date : 30th May 2024
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-
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
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 - 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
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
510K Submission Process for Medical Devices
Overview: There are three types of 510(k) submissions that can be submitted – Traditional, Spec..
Date : 25th August 2023
Time : This Event is Over and the Recorded Content is Available
Duration : 75 Mins
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
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
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
Preparing a FDA 510(k) submission - What to Know in 2025
Overview: The FDA 510(k) submission process remains one of the most crucial regulatory pathwa..
Date : 26th June 2025
Time : 1:00 PM Eastern Time / 10:00 AM Pacific Time
Duration : 75 Mins