WEBINARS

 

Compliance Training Webinars for Regulated Industries

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The 6 Most Common Problems in FDA Software Validation and Verification

webinar-speaker   David Nettleton

webinar-time   120 Min

Product Id: 705582

This training on FDA software validation and verification will provide you the best practices necessary to ensure that all systems are validated in compliance with FDA regulations.

4 / Jun / 2025 - Wednesday

* Per Attendee $249

 

Toxic Substance Control Act (TSCA) Awareness Training 101

webinar-speaker   Joe Keenan

webinar-time   90 mins

Product Id: 706205

Attend this training to understand all the requirements of the Toxic Substance Control Act (TSCA), its revisions, and how to develop a written plan, TSCA Training Plan. Get answers to your TSCA questions.

5 / Jun / 2025 - Thursday

* Per Attendee $199

 

Effective Systems for Change Control in the Pharmaceutical Industry

webinar-speaker   David L Chesney

webinar-time   90 mins

Product Id: 705002

This webinar will help you understand GMP requirements for change control from a pharmaceutical manufacturing perspective, the purpose of change control and what types of changes are or are not subject to change control. Participants will learn how to execute and implement a change in a regulated environment.

9 / Jun / 2025 - Monday

* Per Attendee $199

 

Strategies to Combat Counterfeit Drugs and Other Supply Chain Threats

webinar-speaker   Michael Esposito

webinar-time   90 Mins

Product Id: 706067

Counterfeit drugs present a real and increasing danger both to patients and companies and require a proactive approach to stay ahead of them.

11 / Jun / 2025 - Wednesday

* Per Attendee $199

 

AML Regulatory Insight for Q1 2025: Implementing recent changes in your financial institution

webinar-speaker   Justin Muscolino

webinar-time   60 Mins

Product Id: 707012

As Compliance Officers, we need to be prepared and be able to communicate with those who will be impacted by the upcoming changes. There are several changes coming our way in 2025.

11 / Jun / 2025 - Wednesday

* Per Attendee $189

 

Analytical Methods, Process, Equipment, Cleaning, and Sterilization Validations

webinar-speaker   John E Lincoln

webinar-time   90 mins

Product Id: 707011

Both the U.S. FDA and EU's MDR expect documented risk-based device test method and design V&V under the GLPs, et al

11 / Jun / 2025 - Wednesday

* Per Attendee $199

 

ISO 13485:2016 Quality Systems

webinar-speaker   Juan M Campos

webinar-time   90 Mins

Product Id: 707013

Compliance with international standard ISO 13485:2016 is mandatory for all medical devices placed in most of the main markets word wide. It is of strategic importance for any medical device manufacturer to understand and effectively apply the ISO 13485:2016 requirements to access these critical markets.

12 / Jun / 2025 - Thursday

* Per Attendee $199

 

Power Analysis for Sample Size Calculations

webinar-speaker   Elaine Eisenbeisz

webinar-time   120 Mins

Product Id: 705873

In this webinar attendees will learn the statistical power analysis and techniques for determining sample size (a priori techniques) calculation. Also attendees will get work examples in the free to use G*Power software. Some code and demonstrations will be provided for powering studies and performing power analysis simulations in R software.

12 / Jun / 2025 - Thursday

* Per Attendee $199

 

Conducting Your 2025 Annual ACH Rules Compliance Audit - a Step-by-Step Guide

webinar-speaker   Donna K Olheiser

webinar-time   90 mins

Product Id: 705082

The Nacha Operating Rules and Guidelines require that all participating depository financial institutions (ODFI & RDFI), Third Party Senders (TPS) and Third-Party Service Providers (TPSP) that provide ACH services to the RDFI or ODFI, conduct an annual ACH audit by December 31 of each year (Nacha Operating Rules, Article 1).

16 / Jun / 2025 - Monday

* Per Attendee $199

 

Conducting and Documenting Robust Investigation for OOS Results

webinar-speaker   Joy McElroy

webinar-time   90 Mins

Product Id: 707016

The FDA sites hundreds of companies each year for not adequately performing and documenting out of specification results. This course is designed to provide instruction on how to thoroughly document and investigate out of specification results using approaches which have been recommended by regulatory authorities.

23 / Jun / 2025 - Monday

* Per Attendee $199

 

21 CFR Part 11, FDA’s Guidance for Electronic Records and Electronic Signatures

webinar-speaker   Carolyn Troiano

webinar-time   90 Mins

Product Id: 707014

The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This includes development of a company philosophy and approach, and incorporating it into the overall computer system validation program and plans for individual systems that have this capability.

23 / Jun / 2025 - Monday

* Per Attendee $199

 

Drug, Device and Combination Product Development

webinar-speaker   John E Lincoln

webinar-time   90 Mins

Product Id: 707015

This webinar provides a basic overview of the stages of development and V&V of the basic categories of medical products, from R&D through Production, and the US FDA regulatory and documentation requirements at the various stages.

24 / Jun / 2025 - Tuesday

* Per Attendee $199

 

USP <61>/<62> Microbiological Enumeration and Examination of Non-Sterile Products – Understanding the Current Standards for the Revised USP and Harmonized EP Microorganisms

webinar-speaker   Barry A Friedman

webinar-time   90 mins

Product Id: 706883

The objective of this live, interactive webinar is to explore the changes to these historic USP test methods, compare them to the new European Pharmacopoeia (EP), 2.6.12 Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests and 2.6.13 Microbiological Examination of Non-Sterile Products: Test for Specified Microorganisms, methodology and how it impacts the typical cGMP microbiological laboratory.

25 / Jun / 2025 - Wednesday

* Per Attendee $199

 

How to Prepare and Survive an EPA Audit

webinar-speaker   Joe Keenan

webinar-time   60 Mins

Product Id: 706857

In this training program attendees will learn the key elements needed to develop a proactive Regulatory Compliance Written Program. After this webinar, you will have confidence in facing the next EPA regulatory compliance audit that comes your way.

1 / Jul / 2025 - Tuesday

* Per Attendee $199

 

Excel Spreadsheets; Ensuring Data Integrity and 21 CFR Part 11 Compliance

webinar-speaker   David Nettleton

webinar-time   75 min

Product Id: 701582

Learn how to use Microsoft Excel spreadsheets for GXP data to ensure compliance with 21 CFR Part 11 and reduce validation cost and time.

1 / Jul / 2025 - Tuesday

* Per Attendee $229

 

Stability Studies and Estimating Shelf Life

webinar-speaker   Steven Wachs

webinar-time   90 Mins

Product Id: 706026

The webinar will provide useful methods and techniques for conducting a stability study and analyzing the resulting data for the purpose of estimating shelf life. Participants should be able to immediately apply the methods presented. Also, the interpretation and communication of results will be stressed and illustrated in several examples.

8 / Jul / 2025 - Tuesday

* Per Attendee $199

 

Hypothesis Testing, P-values and Inference: When Thinking like a Statistician Makes Sense

webinar-speaker   Elaine Eisenbeisz

webinar-time   120 Mins

Product Id: 703552

This clinical research webinar will explore the reasoning that formulates null hypotheses and turns researchers’ hair gray. Attendees will learn the why and how of the scientific method and how to view the world with a statistician’s eyes. Also attendees will learn the possibilities and limitations of research questions and hypothesis development, how to interpret statistical findings with p-values, effect sizes, and confidence intervals.

10 / Jul / 2025 - Thursday

* Per Attendee $229

 

Conducting an ACH Risk Assessment and Developing an Effective Risk Management Program

webinar-speaker   Donna K Olheiser

webinar-time   90 Min

Product Id: 706995

According to the Nacha Operating Rules, financial institutions are required to assess and manage all ACH risks, which includes developing a Risk Management program. Most ACH risk can be mitigated through proper due diligence for all originating customers (KYC) and strict adherence to ACH origination and credit policies, which includes monitoring ACH activity.

23 / Jul / 2025 - Wednesday

* Per Attendee $199

 

Ethylene Oxide (EO) Sterilization Basics for R&D Engineers

webinar-speaker   Gerry O Dell

webinar-time   90 Mins

Product Id: 701272

This Sterilization training will provide valuable information to companies that design products for terminal sterilization with ethylene oxide.

24 / Jul / 2025 - Thursday

* Per Attendee $199

 

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

webinar-speaker   David Nettleton

webinar-time   90 Mins

Product Id: 701687

This 21 CFR Part 11 compliance training will guide you through the requirements of Part 11 and will also explain its 3 primary areas: SOPs, product features and validation (10 step risk based approach).

5 / Aug / 2025 - Tuesday

* Per Attendee $229

 

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