Compliance Training Webinars for Regulated Industries

This webinar will focus on the current trends in FDA Inspections and guidelines and how this information can be utilized to provide a foundation for compliance with the latest quality and regulatory requirements. Attendees will learn how to proactively prepare for an inspection.

Part 1 -- NEW changes to the Nacha Operating Rules include "minor" Rules changes - effective June 21, 2024 (no major impact on operations but a must know to remain in compliance - by knowing the things they are clarifying in the minor Rule change topics). In addition, Risk Management Topics - effective Oct 1, 2024 (covering topics that were proposed before but now really happening) - such as "Expanded use of Return Reason Codes R06 and R17"; "funds availability exceptions" and "Unauthorized Return changes for the RDFI with timing of the WSUD and returning the unauthorized transaction".

As a “GxP” system, following Good Manufacturing, Laboratory and Clinical Practices, the computer system must be validated in accordance with FDA requirements. If electronic records and/or electronic signatures (ER/ES) are incorporated into the system, FDA’s CFR Part 11 guidance on ER/ES must be followed to assure data integrity is maintained. This webinar will focus on the efforts by FDA to modernize their own technology infrastructure, and what this means to industry. We will cover the Technology Modernization Action Plan (TMAP) that has been launched by FDA for this purpose and discuss specific actions that are planned and in progress.

This webinar will help you understand the requirements of the new medical device regulation EU MDR 745/2017 and teach you how to create new required reports for the Notified Body and the Competent Authorities and how this process is connected to other processes in the quality management system according EN ISO 13485:2021.

The U.S. FDA and EU's MDR require specific steps to be fulfilled to develop and/or transfer analytical methods to maintain accuracy.

BSA rules and regulations must be followed by financial institutions. Although financial institutions have been managing BSA operations in accordance with regulatory requirements, the shift to BSA audits has become increasingly important. Regulators look to the financial institution for confirmation and proof that BSA operations are being audited properly to ensure that BSA efforts are implemented and managed properly.

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).

This targeted 60-minute U.S. Reimbursement training/webinar will help you understand and navigate the complex U.S. system for understanding product reimbursement status and potential for your Medical Device

Substandard medications, like counterfeit drugs, present a real and increasing danger both to patients and companies and require a proactive approach to stay ahead of these problems.

This webinar will teach you how to get proactive and put programs in place to prevent a workplace violence episode and how to respond to an active shooter scenario. This training will discuss in detail the Do's and Don'ts in reference to workplace violence prevention.

Part 2 – Effective March 20, 2026, two Rule amendments (Fraud Monitoring – Phase 1) – monitoring for Faud (as part of a larger Risk Management package) intended to reduce the incidence of successful fraud attempts and improve the recovery of funds after frauds have occurred.

This webinar will teach you how to conduct an effective management review of the quality system which helps you understand how to plan and focus on right metrics and governed by an efficient process. Participants will also understand FDA policy regarding disclosure of management review information during inspections.

This webinar provides a basic understanding and fundamental principles of Current Good Manufacturing Practices and will fulfill the requirement of personnel involved in cGMP must have documented training of current Good Manufacturing Practices. This session will focus on the FDC Act and 21 CFR federal regulations as applied to cGMP.

This webinar will address the responses or actions that should be taken when an excursion in the alert or action level occurs during environmental monitoring including bioburden. In addition, this environmental monitoring training will review the best practices for setting environmental monitoring alert and action levels for viable and non-viable data including product bioburden.

This webinar will focus on the computer systems and data that are regulated by FDA. These systems will require validation and the data must be created and maintained with integrity. We’ll cover what is required for Computer System Validation (CSV) and we’ll discuss the new draft guidance from FDA on Computer Software Assurance (CSA). We’ll also cover 21 CFR Part 11, FDA’s guidance for electronic records and electronic signatures. Finally, we’ll discuss the “ALCOA+” requirements for data integrity.

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.

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.

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.

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

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.