Recorded Webinars

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Prepare for FDA QMSR Inspections: 483 & Warning Letter Response

Prepare for FDA QMSR Inspections: 483 & Warning Letter Response

Overview: FDA inspections under the new QMSR can look and feel different—not just in what inv..

Date : 23rd February 2026

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

Duration : 60 Mins

ISO 13485:2016 Utilizing Principles of Lean Documents and Lean Configuration

ISO 13485:2016 Utilizing Principles of Lean Documents and Lean Configuration

Overview: Medical device and life science organizations are expected to maintain a Quality Ma..

Date : 20th February 2026

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

Duration : 75 Mins

Overtime, Exemptions & Salary Thresholds under FLSA (2026)

Overtime, Exemptions & Salary Thresholds under FLSA (2026)

Overview: In 2026, overtime and exemption decisions have become a moving target for payroll a..

Date : 18th February 2026

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

Duration : 60 Mins

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

An Advanced Course on Lean Documents, Lean Configuration, and Document Control - What to Know

An Advanced Course on Lean Documents, Lean Configuration, and Document Control - What to Know

Overview: In today’s life sciences environment, document control is often where “lean” quietl..

Date : 26th January 2026

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

Duration : 90 Mins

FDA’s QMSR is Coming: Practical Readiness for Quality Teams

FDA’s QMSR is Coming: Practical Readiness for Quality Teams

Overview: With the FDA’s Quality Management System Regulation (QMSR) taking effect in February..

Date : 21st January 2026

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

Duration : 60 Mins

EEOC New Stance on Workplace Harassment - What Employers Must Update in their Policies and Investigations

EEOC New Stance on Workplace Harassment - What Employers Must Update in their Policies and Investigations

Overview: On April 29, 2024, the EEOC issued its first comprehensive workplace-harassment gui..

Date : 25th November 2025

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

Multi-State Payroll Tax Compliance 2025: Managing Remote Work, Reciprocity & SUI Challenges

Multi-State Payroll Tax Compliance 2025: Managing Remote Work, Reciprocity & SUI Challenges

Overview: Running payroll across multiple jurisdictions is no longer an edge case—it’s the wee..

Date : 18th November 2025

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

Duration : 60 Mins

Exempt vs, Non-exempt and how the FLSA Defines Each

Exempt vs, Non-exempt and how the FLSA Defines Each

Overview: The Fair Labor Standards Act (FLSA) continues to be one of the most critical and co..

Date : 03rd November 2025

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

Duration : 60 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

FDA’s Q-Submission Program for Medical Devices, Software-in-a-Medical Device Products & SaMD with Considerations for Using AI & ChatGPT

FDA’s Q-Submission Program for Medical Devices, Software-in-a-Medical Device Products & SaMD with Considerations for Using AI & ChatGPT

Overview: The U.S. Food and Drug Administration (FDA) has taken a major step toward modernizi..

Date : 22nd 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

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