Compliance Training Webinars for Regulated Industries

Computer system validation and risk-based verification and validation planning to meet US FDA and ISO 13485 requirements

This 90-minute webinar will show how you can implement a closed-loop CAPA system that meets CGMP requirements and U.S. FDA expectations. You will learn simple, but powerful, tools and methods that you can use regularly and systematically to define and resolve root causes, not just symptoms.

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.

This session will help the attendee to identify a Third-Party Sender (TPS) and a “nested” TPS. In addition, we will cover the details needed in the agreements between all parties and what parties based on their role. Discussion on the registration requirement for both the TPS and the nested TPS and what that means to the ODFI.

This GLP quality system webinar provides a general overview of the Proposed Rule, a GLP QMS and its implementation, GAP analysis, Plan-Do-Check-Act cycle, process control and optimization theory and quality audits are utilized for the analysis of an existing QMS and the potential benefits, barriers steps to implementing an optimized GLP QMS.

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.

This FDA compliance training will cover in detail the new requirements for trial master files including documents related to clinical trials that are required to be prepared, collected and maintained as part of the TMF.

This webinar will discuss dealing with supplier change notices. Regulatory agencies have the expectation that a manufacturer has control over its supply chain and dealing with changes to that supply chain can be challenging.

This training will evaluate the chief areas of an FDA cGMP compliance audit and help you understand the actual and anticipated changes in emphasis based on this new regulatory climate. It will prepare you and your company for tougher US FDA cGMP compliance audits.

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.

This training program will examine how human factors/usability is the analysis of how people interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process, and validating the effectiveness of the studies will be explained. The various types and methods of human factors analysis will be explained. This process conforms to the new ISO 62366 standard and the new FDA guidance document.

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

Recent updates to the Nacha Operating Rules were developed to enhance the ACH “user” experience with improvements and simplification by adopting new technologies and channels for the authorization and initiation of ACH payments. Included in the change was a reduction to the barriers when using the ACH Network by providing clarity and increasing consistency pertaining to certain ACH authorization processes and by reducing some of the administrative burdens related to ACH authorizations. What does all this mean will be covered in this 90-minute webinar, explaining how this new Rule applies (and it is optional for Originator/ODFI).

This webinar will discuss setting up statistically justified sampling plans for process validation. Discussion will also involve using the sampling plan to set acceptance criteria for process validation. Setting acceptance criteria for test method validation will also be presented.

Cybersecurity is the art of protecting networks, devices, and data from unauthorized access or criminal use. It is the practice of ensuring confidentiality, integrity, and availability of information.

This training program will take attendees through the actions to take when confronted with an active shooter and in assisting responding law enforcement officials. It will help recognize potential workplace violence indicators and describe actions to take to prevent and explore the General Duty Clause of the OSH Act.

This webinar will provide participants with a comprehensive understanding of the Americans with Disabilities Act and will explain the importance of compliance and the consequences of non-compliance. Participants will gain a solid understanding of the ADA’s disability accommodation process and the interactions between Federal and State laws.

This webinar will help you identify factors that cause delays as patients progress through their stay and how to correct these barriers to care. Learn the most streamlined ways in which to integrate avoidable delay management into your day and with all the members of the interdisciplinary care team. Finally, it will review some examples of report cars that can be used to understand the data you have collected.

Attend this webinar to learn the importance of doing a complete impact assessment prior to implementation of changes under change control. Tools and techniques will be presented to aid in organizing and streamlining impact assessments.

This webinar will explain how to perform anti-fraud audits in the purchasing/accounts payable cycle. It will discuss the use of Audit Control Language (ACL) and how this tool and other tools like it (IDEA) are helpful in the analysis of accounts payable and purchasing data.