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Business Process Mapping – How to Prepare a Detailed System & Data Roadmap for a Clinical Trial Regulated by FDA

Business Process Mapping – How to Prepare a Detailed System & Data Roadmap for a Clinical Trial Regulated by FDA

Overview: Conducting human clinical trials requires strict adherence to government regulatory ..

Date : 30th 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

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

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

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

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

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

Functional and System Requirements for Systems Regulated by FDA - New Updates Included

Functional and System Requirements for Systems Regulated by FDA - New Updates Included

Overview: Computer System Validation (CSV) has been regulated by FDA for more than 35 years, a..

Date : 28th June 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

Data Integrity and Governance for Computer Systems Regulated by FDA

Data Integrity and Governance for Computer Systems Regulated by FDA

Overview:The Webinar will focus on the importance of ensuring that the validation of an FDA-regulate..

Date : 27th September 2022

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

Duration : 90 Mins

Water Systems in Pharmaceutical Manufacturing Industry

Water Systems in Pharmaceutical Manufacturing Industry

Overview: This seminar will provide an overview of water systems used for pharmaceutical manu..

Date : 22nd September 2022

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

Duration : 60 Mins

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