WEBINARS

 

Compliance Training Webinars for Regulated Industries

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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

 

Fair Lending in 2025: new regulations, examinations and enforcement

webinar-speaker   Justin Muscolino

webinar-time   60 Mins

Product Id: 707017

Are you as knowledgeable in the Fair Lending regulations? Do you know how they pertain to your role and responsibilities? Has your compliance program changed with the changes in regulations? During this webinar we will go through each of the regulations that fall under Fair Lending and take look at the latest developments in regulatory compliance.

14 / Jul / 2025 - Monday

* Per Attendee $199

 

Ethylene Oxide and Gamma Radiation Sterilization Validations

webinar-speaker   John E Lincoln

webinar-time   90 Mins

Product Id: 707018

Gamma and EO Sterilization verification and validations under the U.S. FDA and EU's EMA / MDR requirements

16 / Jul / 2025 - Wednesday

* Per Attendee $199

 

Current Trends in FDA Inspections

webinar-speaker   Michael Ferrante

webinar-time   90 Mins

Product Id: 703485

This webinar will focus on the current trends in FDA inspections and guidelines that can be implemented to ensure compliance with the latest quality and regulatory requirements. Attendees will learn how to prepare for an FDA inspection to avoid Warning Letters.

17 / Jul / 2025 - Thursday

* Per Attendee $199

 

Preparing for Pre-Approval Inspections

webinar-speaker   Joy McElroy

webinar-time   90 Mins

Product Id: 707019

A pre-approval inspection (PAI) is performed to provide the Food and Drug Administration (FDA) assurances that a manufacturing site named in a drug application is capable of consistently manufacturing a safe drug product, and that the submitted data is accurate and complete against what was filed in their application. This training will provide guidance on when the FDA performs pre-approval inspections. It will describe how to prepare for a PAI, and the outcomes of pre-approval inspections.

18 / Jul / 2025 - Friday

* Per Attendee $199

 

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

 

Clinical Trial Systems: The Trial Master File (TMF) and Electronic Trial Master File (eTMF)

webinar-speaker   Carolyn Troiano

webinar-time   90 Min

Product Id: 706938

Companies engaged in the conduct of human clinical trials must adhere to specific government regulatory requirements. Certain documents, content and images related to a clinical trial must be stored and maintained, and depending on the regulatory jurisdiction, this body of information may be stored in a trial master file (TMF). All of the data and documents supporting the planning, conduct and evaluation of a clinical trial must be of the highest integrity, which must be maintained through their entire life cycle. Computer System Validation will be discussed as a key methodology for meeting all of these requirements and assuring data/document integrity.

28 / Jul / 2025 - Monday

* Per Attendee $189

 

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

 

EPA Tier II Reporting

webinar-speaker   Joe Keenan

webinar-time   60 Mins

Product Id: 705125

This training program will enumerate the requirements of the Emergency Planning and Community Right-to-Know Act (EPCRA) as it applies to your organization. It will also help attendees understand the threshold trigger for reporting a hazardous chemical on the Tier II forms and learn how to accurately calculate chemical mixtures as it applies to the Tier II forms. Further, attendees will learn to navigate the complexities of online Tier II reporting.

6 / Aug / 2025 - Wednesday

* Per Attendee $189

 

Process Capability for Normal and Non-Normal Data (Focus: Process Stability, Capability and Cp, Cpk, Pp, Ppk, Cpm)

webinar-speaker   Steven Wachs

webinar-time   75 Mins

Product Id: 705020

This webinar discusses methods for estimating process capability for both normal and non-normal data. Methods include estimating the proportion of defective products that may be produced as well as the calculation and use of common process capability indices (e.g. Cpk and Ppk). Process Capability assessments are discussed in the overall context of quality improvement/management.

7 / Aug / 2025 - Thursday

* Per Attendee $189

 

The 6 Most Common Problems in FDA Software Validation and Verification

webinar-speaker   David Nettleton

webinar-time   120 Mins

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.

9 / Sep / 2025 - Tuesday

* Per Attendee $249

 

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