Compliance Training Webinars for Regulated Industries

This course will give an introduction into the new ISO 14971:2019 and how to create a risk management file according the ISO 14971:2019. It will give you an overview about the requirements the interfaces to Post-Market-Surveillance, Clinical Evaluation, Bench-Testing and Life-Cycle-Management. and how a smart implementation of these requirements in your product documentation is possible and finally what are the expectations of the European Notified Bodies.

The webinar will provide an update of key federal and state unemployment issues. Participants will gain an understanding of the critical issues affecting their individual Unemployment Insurance (UI) accounts and develop methods to control UI costs and manage other related liabilities.

Sound management of operational risk is an integral part of strong governance, risk and compliance (GRC) and enterprise risk management. In this session, the instructor will define operational risk and explain how to identify, quantify, manage, and control it. He will discuss why all employees must be cognizant of these risks in their day to day jobs and how an organization can better manage and control these risks that have resulted in the failure of several high profile firms and significant losses and unwanted press at others. The course will also review and discuss the building blocks and key players in implementing an effective ORM program that is integrated into the enterprise risk management framework.

ISO 11135:2014: “Sterilization of health-care products – Ethylene oxide – Requirements for the development, validation and routine control of a sterilization process for medical devices”, defines the latest requirements for the validation of Ethylene Oxide sterilization of medical devices, the sterilization chamber, and sterilization controls. This webinar will use ISO 11135 as a basis for a field-tested approach to sterilization validation and its documentation, including the chamber control software.

This webinar will make your understand regulatory requirements of veterinary medical device. How to differentiate regulations of human and veterinary medical devices, manufacturing requirements, safety standards, labelling requirements, how to draft the SOPs covering material intake, production, quality control, packing, distribution and sales.

The letters ‘CE’ appear on many products that are traded on the single market in the European Economic Area (EEA). By placing the CE mark on a product, a manufacturer is declaring, on his sole responsibility, conformity with all of the legal requirements necessary to achieve CE marking status. With that mark, the manufacturer is ensuring validity for that product to be sold throughout the EEA. CE marking does not mean that a product was made in the EEA, but states that the product is assessed before being placed on the market. It means the product satisfies the legislative requirements to be sold there.

This 2-hr webinar on Service Level Agreements (SLAs) will provide you with sound principles and a set of guidelines for developing and preparing ‘effective’ Service Level Agreements (SLAs) for an internal service function or an outside service provider.

This presentation reviews the six levels of metdata level processing that all organizations need to be aware of and plan for. In the current days of automation in our daily lives at home, in the car and in various industries, FDA submissions in the pharma industry is next in line for more automation through metadata. We will explore examples for each of the metadata level. Metadata will be reviewed to understand how metadata has answers to key questions for logical processing. SAS tools will be reviewed to write code for more automation process.

In addition to the FMLA and the ADA, now we have the Families First Coronavirus Response Act (FFCRA), mandating paid leave for many employees for COVID-related reasons. In this webinar, we will discuss key, hot-button compliance issues and share some Best Practices for managing a workforce while staying in compliance with the FFCRA, the FMLA, ADA, and Workers’ Comp.

The United States' loss of manufacturing capability in the past decades has led to a decline in the nation's standard of living, and has also weakened its geopolitical strength. The COVID-19 outbreak has meanwhile underscored the vulnerabilities of extensive supply chains that include unreliable trading partners. Proven off-the-shelf methods and principles are however available to rebuild the United States' manufacturing capability and make it more profitable for all stakeholders.

This zero tolerance for injuries training program will discuss what it means to have a safety culture on site. It will also identify the four steps of the safety maturity curve and discuss employee and employer rights and responsibilities at each step of the maturity curve. The instructor will explain the benefits of sustaining a safety culture in the workplace.

Have you struggled with the question - “When do I use a Stop Pay form and when do I need a Written Statement of Unauthorized Debit (WSUD)?” This is YOUR session! The trainer in this session will provide examples of when to use which form and why plus tying this information back to what the NACHA Operating Rules state to ensure you are in compliance each time you help your account holder with their request. With the newly adopted Rules change for 2020 with “unauthorized returns” what Return Reason code do I use and why? Return Reason Code R10 or R11 and what is the difference when using these to return Entries as unauthorized? Key points illustrated during this virtual workshop will assist your customer service and front-line staff as well as your operations staff.

This HR Audit webinar will cover key strategic, operational, and compliance HR management issues. The objective is to provide the attendee with the key areas that should be addressed in conducting an HR audit, an understanding of critical tasks to be completed, and an update how federal and state employment laws may affect the scope and the reporting of the HR audit.

This ICD-10-CM webinar will cover day-to-day complex challenges for coding professionals and CDI professionals, which includes advanced areas of the coding guidelines, coding conventions, strategies to address documentation issues and query best practices. It will also review challenging CDI, coding and audit case scenarios and review query examples, coding references and clinical indicators on common diagnoses considered as complications/comorbidities (CC) and major complications/comorbidities (MCC).

This webinar will explore the area of training in regulated environments, its importance, and its relationship to compliance documentation. You will learn how to achieve world-class compliance, improved operational performance, improved quality, and improved employee/associate safety through training.

ISO 14971:2019 requires an overall Benefit-Risk Analysis but many companies struggle with constructing the rationale for demonstrating overall benefits outweigh overall risks. This webinar will provide one systematic approach which has proved successful for approaching the analysis.

This webinar will review FDA's regulatory oversight of stem cell-based products when used in humans and analyze its potential impact on the industry in the future. Learn FDA's criteria for marketing and promotion of stem cell-based products for therapeutic application.

Almost two years ago the US FDA announced new steps necessary to modernize FDA’s 510(k) clearance pathway, but companies have been slow to respond, leading to unnecessary delay in achieving marketing clearance. This was reiterated one year ago in the FDA’s Medical Device Safety Action Plan and the related Draft Guidance Document. These steps are viewed by the Agency as a top priority, and provide insight into the Agency’s thinking about what a 510(k) could do to advance medical benefits to the patient.

This training session focuses on the email aspect of Outlook. In this session you'll learn how, used in the right way, Outlook can save you time, help you to gain more control over your mailbox, improve your response time and allow you to keep up with the never-ending stream of critical actions and due dates.

For external analysts, financial statements are a key source of information for getting an understanding of how risk a financial institution can be. Yet, still too many people are tempted to think that financial statements are designed to provide a true and fair view on risks. Do we know how much of the risks are genuinely communicated via financial statements?