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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 November 2024
Time : This Event is Over
Duration : 75 Mins
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 : 21st October 2024
Time : This Event is Over and the Recorded Content is Available
Duration : 90 Mins
21 CFR Part 820 - Quality System Regulation - Applying Principles of Lean Documents and Lean Configuration
Overview: 21 CFR Part 820 delineates the Quality System Regulation (QSR) that governs all ent..
Date : 23rd July 2024
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 2024
10 Minutes excerpt from the recorded event for your review: Best Practices in Preparation for a..
Date : 22nd July 2024
Time : This Event is Over and the Recorded Content is Available
Duration : 90 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
Excel Spreadsheet in FDA Environment - Ensuring Data Integrity and 21 CFR Part 11 Compliance in 2024
Overview:The use of Excel in FDA-regulated environments extends beyond basic data organization and a..
Date : 15th May 2024
Time : This Event is Over
Duration : 90 Mins
Risk-Based Approach to Validating IT Infrastructure Used for FDA-Regulated Systems
Overview: For over three decades, the FDA has regulated computer system validation (CSV) acro..
Date : 25th March 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
Nacha Rule – Third-Party Sender (TPS) Roles and Responsibilities - What to Know
Overview: In 2022, Nacha implemented significant updates to its Operating Rules to enhance cl..
Date : 20th March 2024
Time : This Event is Over and the Recorded Content is Available
Duration : 90 Mins
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
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
FDA Technology Modernization Action Plan (TMAP) and Impact on Regulated Computer Systems and Data Integrity
Overview: For over three decades, the FDA has regulated computer system validation in industr..
Date : 27th November 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 -
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
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
How to Conduct an ACH Risk Assessment and Develop an Effective Risk Management Program
Overview:Whether you're a Financial Institution, Third-Party Service Provider (TPSP), or Third-Par..
Date : 27th September 2023
Time : This Event is Over and the Recorded Content is Available
Duration : 90 Mins