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Risk-Based Approach to Validating IT Infrastructure Used for FDA-Regulated Systems

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-

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

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FDA Recent Draft Guidance Related to 21 CFR Part 11, Electronic Records/Signatures for Clinical Investigations

FDA Recent Draft Guidance Related to 21 CFR Part 11, Electronic Records/Signatures for Clinical Investigations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

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

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 -

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

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: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

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

FDA Compliance and System Validation for Tobacco and Related Products

FDA Compliance and System Validation for Tobacco and Related Products

Overview:In this webinar, We will explore the significance of applying industry-best practices duri..

Date : 31st July 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

Excel Spreadsheet in FDA Environment - Ensuring Data Integrity and 21 CFR Part 11 Compliance

Excel Spreadsheet in FDA Environment - Ensuring Data Integrity and 21 CFR Part 11 Compliance

Overview:Join us for an interactive webinar that demystifies the process of configuring and valida..

Date : 22nd May 2023

Time : This Event Is Over

Duration : 90 Mins

Excel Spreadsheets in FDA Environment - Data Integrity and 21 CFR Part 11 Compliance

Excel Spreadsheets in FDA Environment - Data Integrity and 21 CFR Part 11 Compliance

Overview: This interactive webinar explains how to configure and validate a GxP compliant sprea..

Date : 27th March 2023

Time : This Event is Over

Duration : 90 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 : 27th February 2023

Time : This Event is Over

Duration : 90 Mins

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