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2026 Nacha Rules Changes (Part 1): Fraud Monitoring & Ops Bulletins

2026 Nacha Rules Changes (Part 1): Fraud Monitoring & Ops Bulletins

Overview: The ACH Network runs on precision—formats, timing, authorizations, monitoring expec..

Date : January 28, 2026

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

Duration : 120 Mins

Risk-Based Excel Spreadsheet Validation and FDA Compliance - Risk-Based CSV/CSA & Part 11

Risk-Based Excel Spreadsheet Validation and FDA Compliance - Risk-Based CSV/CSA & Part 11

Overview:FDA inspections and audits continue to put a bright spotlight on data integrity—especiall..

Date : 27th January 2026

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

Duration : 90 Mins

Transition from CSV to CSA; FDA Final CSA Guidance, September 2025 for Medical Device Manufacturing & Quality Testing

Transition from CSV to CSA; FDA Final CSA Guidance, September 2025 for Medical Device Manufacturing & Quality Testing

Overview: For decades, life-science teams have relied on Computer System Validation (CSV)—sha..

Date : 21st November 2025

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

Duration : 90 Mins

Excel Spreadsheet in FDA Regulated Environment - Validating Excel for GxP & 21 CFR Part 11

Excel Spreadsheet in FDA Regulated Environment - Validating Excel for GxP & 21 CFR Part 11

Overview: The use of Excel in FDA-regulated environments goes far beyond basic analysis. When ..

Date : 21st November 2025

Time : This Event is Over

Duration : 75 Mins

Project Management for CSV in FDA-Regulated Environments (CSA, GAMP®5 2nd Ed.) — with a Brief AI/ChatGPT Overview for PM Support

Project Management for CSV in FDA-Regulated Environments (CSA, GAMP®5 2nd Ed.) — with a Brief AI/ChatGPT Overview for PM Support

Overview: Computer System Validation (CSV) has underpinned FDA compliance in regulated industr..

Date : 30th October 2025

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

Duration : 90 Mins

Clinical Trial Systems: Trial Master File (TMF) and eTMF, & FDA’s Recent Draft Guidance for Electronic Records/Signatures Used in Clinical Trials

Clinical Trial Systems: Trial Master File (TMF) and eTMF, & FDA’s Recent Draft Guidance for Electronic Records/Signatures Used in Clinical Trials

Overview: Organizations involved in the conduct of human clinical trials must meet rigorous re..

Date : 30th September 2025

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

Duration : 90 Mins

Validation of FDA-Regulated Systems with AI, ML & LLMs (ChatGPT)

Validation of FDA-Regulated Systems with AI, ML & LLMs (ChatGPT)

Overview: Life science industries — including pharmaceutical, medical device, biotechnology, ..

Date : 11th September 2025

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 - 2025

Data Integrity and Privacy - Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR - 2025

Overview: In today's rapidly evolving life sciences landscape, ensuring data integrity and pr..

Date : 21st August 2025

Time : This Event is Over

Duration : 75 Mins

The 6 Most Common Problems in FDA Software Validation and Verification in 2025

The 6 Most Common Problems in FDA Software Validation and Verification in 2025

Overview: Professionals working with FDA-regulated software face numerous challenges when it co..

Date : 12th June 2025

Time : This Event is Over

Duration : 75 Mins

Excel Spreadsheet in FDA Regulated Environment - Ensuring Data Integrity and 21 CFR Part 11 Compliance in 2025

Excel Spreadsheet in FDA Regulated Environment - Ensuring Data Integrity and 21 CFR Part 11 Compliance in 2025

Overview:The use of Excel in FDA-regulated environments extends beyond basic data organization and a..

Date : 11th April 2025

Time : This Event is Over

Duration : 90 Mins

Data Integrity and Privacy - Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR in 2025

Data Integrity and Privacy - Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR in 2025

Overview: In today's rapidly evolving life sciences landscape, ensuring data integrity and priv..

Date : 14th February 2025

Time : This Event is Over

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, biotech..

Date : 13th January 2025

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

Duration : 90 Mins + Q&A

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

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

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

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

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