Compliance Training Webinars for Regulated Industries

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.

This training program will detail the functions of the Federal Communications Commission (FCC) and the Telecommunications Certification Body (TCB). It will breakdown the contents of the FCC Form 740 and offer guidance for effectively completing the form.

This webinar will instruct participants on the new penalties issued to individuals and employers who lack coverage altogether or whose healthcare coverage fails to meet Affordable Care Act (ACA) standards. Attendees will also learn how to compute the required annual payment, i.e., the shared responsibility payment. This two-hour webinar will focus on requirements set forth for individuals and employers filing the new form 1095-C.

No two investigations are the same – even a seasoned veteran who has handled discrimination complaints and conducted internal investigations can still benefit from a deeper understanding of how to ensure EEO compliance. The risk of not properly conducting an investigation is substantial in terms of fines, penalties and settlements, but also court costs and deterioration in the organization’s reputation. This webinar will present plain language ideas for conducting investigations.

This webinar will focus on the key elements that employers need to know in order to avoid potential fiduciary liability under Employee Retirement Income Security Act (ERISA). It will cover who is a fiduciary, the responsibilities of fiduciaries and how to implement safeguards to reduce the potential for ERISA liability.

This training program will instruct attendees to better understand ethical and legal requirements when conducting medical/clinical research and study. The webinar will focus on what/how to identify, address and prevent fraud in medical research.

This webinar will help attendees understand the FDA and EU inspection process and how to prepare for both of them. Attendees will learn the best practices to respond to Form 483 citations, Warning Letters and EU inspection findings.

This FDA guidance training on RUO (Research Use Only) and IUO (Investigational Use Only) products will enumerate FDA requirements for research use only and investigational use only IVD products. The webinar instructor, an industry expert, will highlight appropriate labeling and distribution practices for RUO and IUO products and detail instructions for use of an IVD product labeled RUO or IUO.

This training program will detail appropriate multiple trade agreements that importers and exporters require when conducting trade transactions, focusing particularly on trade requirements and procedures while exporting to Mexico. The webinar will provide import compliance materials that examine U.S. Customs and Border Protection regulations for record keeping that can be used in the international logistic arena.

This training program will offer an overview of the Fair Labor Standards Act (FLSA) which is the guiding law pertaining to classification, deductions, travel time, not tracking hours worked and misclassifying independent contractors. It will also focus on leading wage and hour violations. Recent case histories will also be reviewed for emphasis.