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Best Practices for Auditing a Vendor of Computer Systems Regulated by FDA

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

GAMP®5, 2nd Edition & FDA's CSA Guidance - Aligning Validation Practices

GAMP®5, 2nd Edition & FDA's CSA Guidance - Aligning Validation Practices

Overview The landscape of computer system validation is undergoing a transformative shift wit..

Date : 30th April 2024

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

Duration : 90 Mins

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

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

FDA Recent Draft Guidance Related to 21 CFR Part 11, Electronic Records/Signatures for Clinical Investigations

FDA Recent Draft Guidance Related to 21 CFR Part 11, Electronic Records/Signatures for Clinical Investigations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

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 Data Governance for Computer Systems Regulated by FDA

Data Integrity and Data Governance for Computer Systems Regulated by FDA

Overview:Navigating the FDA's guidelines on computer system validation is no simple task, particul..

Date : 26th 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

Mastering Mobile App Validation in FDA-Regulated Environments

Mastering Mobile App Validation in FDA-Regulated Environments

Overview: In this webinar, we will delve into the critical aspects of applying computer syste..

Date : 26th May 2023

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

Duration : 90 Mins

Data Privacy: Navigating CPRA, HIPAA & GDPR Compliance Requirements for Industry

Data Privacy: Navigating CPRA, HIPAA & GDPR Compliance Requirements for Industry

Overview: The California Privacy Rights Act (CPRA) passed by voters in 2020 came into effect ..

Date : 21st April 2023

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

Duration : 90 Mins

Good Documentation Practices to Support FDA Computer System Validation

Good Documentation Practices to Support FDA Computer System Validation

Overview: Computer system validation has been regulated by FDA for more than 30 years, as it ..

Date : 29th March 2023

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

Duration : 90 Mins

FDA Technology Modernization Action Plan (TMAP) and Impact on Regulated Computer Systems and Data

FDA Technology Modernization Action Plan (TMAP) and Impact on Regulated Computer Systems and Data

Overview: Computer system validation has been regulated by FDA for more than 30 years, as it re..

Date : 23rd February 2023

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

Duration : 90 Mins

Best Practices for Responding to a Form 483 Citation and/or Warning Letter Issued by FDA

Best Practices for Responding to a Form 483 Citation and/or Warning Letter Issued by FDA

Overview: FDA has substantial authority to oversee regulated companies and their operations.&n..

Date : 30th November 2022

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

Duration : 90 Mins

Clinical Trial Master File (TMF) and electronic Clinical Trial Master File (eTMF) and FDA Compliance

Clinical Trial Master File (TMF) and electronic Clinical Trial Master File (eTMF) and FDA Compliance

Overview: Companies engaged in the conduct of human clinical trials must adhere to specific g..

Date : 28th October 2022

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

Duration : 90 Mins

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