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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

2024 I-9 Form Update: Essential Changes and Audit Compliance

2024 I-9 Form Update: Essential Changes and Audit Compliance

Overview: The recent updates to the Form I-9 and Employment Authorization Document (EAD) guide..

Date : 12th November 2024

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

Duration : 90 Mins

Preparing a FDA 510(k) submission - What to Know in 2024

Preparing a FDA 510(k) submission - What to Know in 2024

Overview: The FDA 510(k) submission process remains one of the most crucial regulatory pathwa..

Date : 29th October 2024

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

Duration : 60 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

Best Practices for Responding to a Form 483 Citation and/or Warning Letter Issued by FDA in 2024

Best Practices for Responding to a Form 483 Citation and/or Warning Letter Issued by FDA in 2024

Overview: The U.S. Food and Drug Administration (FDA) plays a critical role in safeguarding p..

Date : 30th August 2024

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 in 2024

An Advanced Course on Lean Documents, Lean Configuration, and Document Control in 2024

Overview: In today's fast-paced life sciences industry, many companies struggle with cumberso..

Date : 20th August 2024

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

Duration : 90 Mins

Medical Device Hazard analysis following ISO 14971 - Understanding The Process in Detail in 2024

Medical Device Hazard analysis following ISO 14971 - Understanding The Process in Detail in 2024

Overview: In the world of medical device development, the US FDA places a high priority on ri..

Date : 14th August 2024

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

Duration : 75 Mins

HR Documentation: How Can HR Professionals and Supervisors Create Litigation Proof Decisions in 2024

HR Documentation: How Can HR Professionals and Supervisors Create Litigation Proof Decisions in 2024

Overview: In the fast-paced world of human resources, documentation isn't just about keeping ..

Date : 08th August 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

Mastering Mobile App & Medical Device Software Validation and Cybersecurity in FDA-Regulated Environments

Mastering Mobile App & Medical Device Software Validation and Cybersecurity in FDA-Regulated Environments

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

Date : 28th June 2024

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

Duration : 90 Mins

Human Factors/ Usability Studies following ISO 62366 , the FDA Guidance and the new FDA Draft Guidance

Human Factors/ Usability Studies following ISO 62366 , the FDA Guidance and the new FDA Draft Guidance

Overview: Human Factors/Usability studies are essential in ensuring that medical devices are ..

Date : 25th June 2024

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

Duration : 75 Mins

Multi-State Payroll Tax Compliance - June 2024

Multi-State Payroll Tax Compliance - June 2024

Overview: Navigating the complexities of multi-state payroll tax compliance can be a daunting ..

Date : 10th June 2024

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

Duration : 60 Mins

The Dos and Donts of Conducting Employee Criminal Background Checks: Staying Compliant with Regulations

The Dos and Donts of Conducting Employee Criminal Background Checks: Staying Compliant with Regulations

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

Date : 07th June 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

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