Upcoming Webinar

Part 2 - NEW Nacha Operating Rules Changes for 2026 and Beyond: IAT Entries, ACH Contact Registry & R90

Part 2 - NEW Nacha Operating Rules Changes for 2026 and Beyond: IAT Entries, ACH Contact Registry & R90

Overview: Each participant in the ACH Network is required to follow the Nacha Operating Rules ..

Date : 18th February 2026

Time : 1:00 PM Eastern Time / 10:00 AM Pacific Time

Duration : 120 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 : 2:00 PM Eastern Time / 11:00 AM Pacific Time

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 : 1:00 PM Eastern Time / 10:00 AM Pacific Time

Duration : 90 Mins

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 : 1:00 PM Eastern Time / 10:00 AM Pacific Time

Duration : 60 Mins

Data Integrity and Privacy - Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR in 2026

Data Integrity and Privacy - Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR in 2026

Overview: In 2026, data integrity and privacy risks don’t sit in one department—they show up ..

Date : 24th February 2026

Time : 1:00 PM Eastern Time / 10:00 AM Pacific Time

Duration : 90 Mins

Carolyn Troiano


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

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

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

Overview: FDA has substantial authority to oversee regulated companies and their operations.&n..

Date : 30th November 2022

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

Duration : 90 Mins

Clinical Trial Master File (TMF) and electronic Clinical Trial Master File (eTMF) and FDA Compliance

Clinical Trial Master File (TMF) and electronic Clinical Trial Master File (eTMF) and FDA Compliance

Overview: Companies engaged in the conduct of human clinical trials must adhere to specific g..

Date : 28th October 2022

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

Pharma 4.0 - Overcoming Data Integrity Issues in the Cloud to Meet FDA Compliance Requirements

Pharma 4.0 - Overcoming Data Integrity Issues in the Cloud to Meet FDA Compliance Requirements

Overview: Computer system validation has been regulated by FDA for more than 30 years, as it ..

Date : 31st August 2022

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

Duration : 1 Hour 40 Mins

Functional and System Requirements for Systems Regulated by FDA

Functional and System Requirements for Systems Regulated by FDA

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

Date : 27th July 2022

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

Duration : 1 Hour 40 Mins

Best Practices in Preparation for an FDA Computer System Audit

Best Practices in Preparation for an FDA Computer System Audit

Overview: FDA requires that all computer systems used to produce, manage and report on “GxP” (G..

Date : 23rd June 2022

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

Duration : 90 Mins

FDA Technology Modernization Action Plan and Impact on Regulated Computer Systems

FDA Technology Modernization Action Plan and Impact on Regulated Computer Systems

Overview: Computer system validation has been regulated by FDA for more than 30 years, as it re..

Date : 31st May 2022

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

Duration : 1 Hour 30 Mins

Functional and System Requirements for Systems Regulated by FDA

Functional and System Requirements for Systems Regulated by FDA

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

Date : 26th January 2022

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

Duration : 1 Hour 50 Mins

FDA Compliance and Mobile Applications - What do you need to know?

FDA Compliance and Mobile Applications - What do you need to know?

Overview:This topic is focused on the use of mobile applications to process data regulated by FDA.&..

Date : 29th November 2021

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

Duration : 1 Hour 33 Mins

Best Practices in Preparation for an FDA Computer System Audit

Best Practices in Preparation for an FDA Computer System Audit

Overview: FDA requires that all computer systems used to produce, manage and report on “GxP” (G..

Date : 30th September 2021

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

Duration : 1 Hour 55 Mins

Best Practices in Preparation for an FDA Computer System Audit - What You Need to Know?

Best Practices in Preparation for an FDA Computer System Audit - What You Need to Know?

Overview: FDA requires that all computer systems used to produce, manage and report on “GxP” ..

Date : 29th July 2021

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

Duration : 1 Hour 40 Mins

In-Depth Testing of Computer Systems Regulated by FDA - What You Need to Know?

In-Depth Testing of Computer Systems Regulated by FDA - What You Need to Know?

Overview:This webinar will focus on testing as a key element of Computer System Validation (CSV). ..

Date : 28th May 2021

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

Duration : 1 Hour 24 Mins

FDA’s Technology Modernization Action Plan and Impact on Regulated Computer Systems and Data

FDA’s Technology Modernization Action Plan and Impact on Regulated Computer Systems and Data

Overview: Computer system validation has been regulated by FDA for more than 30 years, as it ..

Date : 28th April 2021

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

Duration : 1 Hour 40 Mins

Data Integrity and Governance for Computer Systems Regulated by FDA - What to Know

Data Integrity and Governance for Computer Systems Regulated by FDA - What to Know

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

Date : 24th March 2021

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

Duration : 1 Hour 46 Mins

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