Compliance Training Webinars for Regulated Industries

This training program will discuss the basics of the Medical Device Reporting (MDR) regulation and review the process for preparing and submitting Electronic Medical Device Reports (eMDRs).

This training program will explain to participants the processes and requirements to become CLIA certified. All U.S. laboratories performing testing of human specimens for the diagnosis, treatment or mitigation of human disease are required by law to be certified under CLIA. Becoming CLIA certified is a complex process, and this webinar will provide a roadmap to obtaining certification, saving time, frustration, and resources.

Understand the regulations applied to most goods imported into the United States and the U.S. marking regulations to follow before exporting goods into the U.S.

The webinar will discuss why policies and handbooks are important and strategies for developing or updating your policies and handbooks. You will be provided with tools for determining the laws that are applicable to your company and resources for developing an employee handbook.

This webinar will teach attendees how to prepare for, manage, and follow up on FDA inspections. It will discuss common pitfalls to avoid during an inspection.

This training program will update participants on the developments regarding OFAC sanctions, OFAC enforcement trends as well as related export control traps for the unwary. The discussion of OFAC sanction developments will give participants an appreciation of the new war chest of punitive measures being deployed in recent executive orders.

This training program will discuss the changes to initial and closing disclosures relative to TILA and RESPA. It will offer attendees a clearer understanding of changes to variance thresholds, affiliate relationships, and illustrate the importance of knowing your fees and avoiding closing delays.

This training program will discuss the historical context of India's current trade policy and overview India's commercial climate and market access issues. The course will also highlight top import and export compliance errors, and strategies for smooth trade facilitation into and out of India.

This training program will provide participants with an essential, basic understanding of U.S. rules and regulations governing international trade. The regulations contain required (and prohibited) business conduct, with penalties for failure to comply including fines, loss of export privileges, and even jail terms. In many cases, banks are required to police transactions they handle and report violations.

This training program will address why internal controls over travel and entertainment (T&E) expenditures are a critical component of the control environment. Although the topic of travel and entertainment abuse is not one that management likes to address, it is a very important indicator of the adequacy of a company’s control environment.

This training program will focus on U.S. import entry compliance and FDA import entry compliance. U.S. import requirements for pharmaceutical products are among the most rigorous of any country. As a result, it is critical for importers of drugs and APIs to know and comply with these requirements. Failure to comply with U.S. import requirements may result in clearance delays or import shipments being refused entry into the U.S.

This training program will discuss what to present to management to exploit – as an opportunity - transitioning to ISO 27001: 2013. It will also detail how to prepare, the assistance available, and what tools exist to inform a justification based on efficiency, awareness and market gains. Getting top management buy-in, which may require hiring a consultant and getting people trained can be barriers to success in sustaining a standards-informed approach to business, no less than for a mandatory management system update that will require funding and, therefore, justification.

This training program will discuss latest requirements for monitoring plans, content and process requirements including FDA monitoring guidance and EU requirements. The webinar will help, sponsors, and CROs in the US, EU and internationally, understand how to effectively draft monitoring plans and comply with the latest FDA and EU inspection requirements for monitoring clinical trials.

This Clinical Laboratory Improvement Amendments (CLIA) training will be valuable to CLIA regulated, non-waived laboratories that run automated analyzers or semi-quantitative kit tests. It will highlight differences between quality control and quality assessment and the proper methods to meet CLIA guidelines.

This webinar will provide attendees tools and tips for conducting workplace investigations that are fair, third-party objective, and legally defensible. It will explain the essential elements of an effective investigation.

Regardless of company size or complexity, all successful financial close processes require continuous communication, comprehensive documentation and a flexible, responsive organization. The degree to which recommendations are implemented will vary based on company size, type of industry, availability of resources, maturity, and management commitment. This webinar will present both strategic and tactical suggestions that can help dramatically improve the fiscal closing process for your accounts payable department.

This webinar on clinical study design will explore the differences among superiority, Non-inferiority (NI), and equivalence trials, including development of the precise research questions necessary to making a decision about appropriate clinical designs.

This dietary supplements quality compliance training will review the FDA regulatory requirements for manufacturing and commercialization of dietary supplements. You will gain a complete understanding of FDA requirements for manufacturing of nutraceuticals, food drugs, and dietary supplements.

This webinar will discuss the current regulatory expectations on how a firm identifies deviations, problems and trends, investigates these to determine the cause, and recommends corrective and preventive actions. It will also explain how to complete these actions and demonstrate how the actions accomplishes the intended correction or prevented the repeated occurrence of the problem.

This presentation will explore the nature of decision making in crisis situations. It will explore the psychology of decision making under stress and overview risk management analysis tools. The webinar instructor will present tips and techniques to identify structural and cyclical changes, improve risk management strategy processes, and identify transparent vulnerabilities.