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FDA Human Factors for Medical Devices: Navigating the New Category 1, 2 & 3 Framework

FDA Human Factors for Medical Devices: Navigating the New Category 1, 2 & 3 Framework

OverviewFDA's 2026 Human Factors guidance has changed the way medical device manufacturers determin..

Date : 28th September 2026

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

Duration : 3 Hours

California Meal & Rest Break Compliance 2026: Hidden Risks, Waivers & Premium Pay

California Meal & Rest Break Compliance 2026: Hidden Risks, Waivers & Premium Pay

Overview A California meal or rest break compliance problem rarely begins with a bad handbook..

Date : 25th September 2026

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

Duration : 120 Mins

21 CFR Part 11 & Data Integrity 2026: CSA, Cloud, AI & Annex 11

21 CFR Part 11 & Data Integrity 2026: CSA, Cloud, AI & Annex 11

OverviewA Part 11 problem rarely begins with someone deliberately ignoring a regulation. More ofte..

Date : 23rd September 2026

Time : This Event is Over

Duration : 75 Mins

Independent Contractor vs. Employee: Rules, Risks & Real-World Decisions in 2026

Independent Contractor vs. Employee: Rules, Risks & Real-World Decisions in 2026

Overview Independent contractor classification has become especially difficult for employers i..

Date : 18th September 2026

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

Duration : 60 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Clinical Trial Systems: Trial Master File (TMF) and eTMF, & FDA’s Recent Draft Guidance for Electronic Records/Signatures Used in Clinical Trials

Clinical Trial Systems: Trial Master File (TMF) and eTMF, & FDA’s Recent Draft Guidance for Electronic Records/Signatures Used in Clinical Trials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

How to Manage the Legal Landmine of the FMLA, ADA and Workers Compensation in the Workplace!

How to Manage the Legal Landmine of the FMLA, ADA and Workers Compensation in the Workplace!

Overview: Understanding how to navigate the Americans with Disabilities Act (ADA) is a legal n..

Date : 23rd September 2025

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

Duration : 90 Mins

Employee Expense Reimbursements: IRS Rules, Accountable Plans, Per Diems & OBBB Updates

Employee Expense Reimbursements: IRS Rules, Accountable Plans, Per Diems & OBBB Updates

Overview: Employee expense reimbursements may seem straightforward, but when handled incorrect..

Date : 15th September 2025

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

Duration : 75 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

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

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

Protect Your Workplace: Comply with the EEOC's New Harassment Guidance

Protect Your Workplace: Comply with the EEOC's New Harassment Guidance

10 Minutes excerpt from the recorded event for your review: Read the LinkedIn Article: Lin..

Date : 11th September 2024

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

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

Understanding the DOL's Proposed Overtime Salary Changes: What Employers Need to Know

Understanding the DOL's Proposed Overtime Salary Changes: What Employers Need to Know

Overview: On August 30, 2023, the U.S. Department of Labor (DOL) issued a significant proposa..

Date : 28th September 2023

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: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

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

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