Compliance Training Webinars for Regulated Industries

This webinar will discuss in detail the requirements of 21 CFR part 11 and updated European Annex 11 regulation including requirements for local, SaaS, and cloud hosting. It will also offer techniques to implement a computer system using risk-based validation to gain maximum productivity and reduce cost by as much as two thirds.

The healthcare environment creates a major challenge in the prevention and intervention of violence. The rate of injuries and illness from violence in the healthcare industry is more than three times greater than violence in all private industry. This training program will explore what makes violence in healthcare unique and its negative ramifications on quality patient care.

This 90-minute webinar will provide valuable assistance to all regulated companies performing and documenting meaningful, results driven 510(k) / change analysis activities, based on the FDA's new Draft Guidance, "510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device", dated October 25, 2017.

FDA regulates advertising and promotion material as labeling. The legal definition of labeling covers just about anything that explicitly or implicitly conveys a message intended to affect a person’s behavior and decision outcomes. How FDA applies its legal tenants of false and misleading information or variations on that theme requires continual updating by FDA and constant re-evaluation by industry. Now the regulatory landscape involves other federal agencies and academic principles in psychology. It has become very complicated and will prove very costly if you knowingly or unknowing walk into one of FDA’s legal snares. This webinar will bring attendees up to speed so you are clearer about what is a problem, what is not a problem and what becomes a risk laden judgment call.

This webinar training will discuss the recent updates in OSHA Recordkeeping and Reporting Requirements. Speaker will explain the major regulatory changes that went into effect January 1, 2015 Participants will gain valuable understanding of 300, 300A and 301 log, new reporting timeline requirements and exemptions.

This webinar will discuss HIPAA audit and enforcement regulations and processes for 2022 and how they apply to covered entities and business associates. Attendees will learn how to prepare for HIPAA audit to avoid fines and penalties for HIPAA violations.

This webinar will evaluate the chief areas of FDA CGMP and EU compliance inspections to see actual and anticipated changes in emphasis, and how to better prepare with a company's proactive internal inspection / audit program.

This webinar will focus on the Key parts of IEC 62366-1:2015 and -2:2016, Human Factors Engineering and Role in Design Control (21 CFR 820.30)l, Design and Development Planning (ISO 13485 7.3) .

In this webinar attendees will understand the rules that are required to classify products in the Harmonized Tariff Schedule. Minimize errors in classification and better prepare your company for import/export audits from the government. It will also assist companies who are eligible for free trade agreements, ex. USMCA, and other agreements, in properly completing Certificates of Origin.

The webinar will discuss how to evaluate if a Title V Air Permit is required at your facility and how to properly fill them out. After the webinar the attendees will have a good general outline of what is required in a Title V Air Permit, how to go about getting the information to fill it out, and a comprehensive question and answer session.

The webinar will review the current testing requirements as defined in the new, revised FDA guidance on Endotoxin and Pyrogen testing. It will further help attendees understand the issues surrounding the Low Endotoxin Recovery (LER) and its regulatory outcome.

This webinar will help attendees understand how to meet the rules that are required to qualify their imports/exports between the three USMCA countries (United States, Canada, and Mexico). In addition, this webinar will present some of the major changes between the NAFTA & the USMCA and how these changes may affect the qualification of your products. Some of these changes may impact your company and require advance preparation to meet compliance requirements.

This personal and business tax returns analysis training program will focus on key areas such as 1040 federal tax returns, K-1 forms, and tax code updates and how they affect bank’s clients. It will also discuss the structure of a C corporation, S corporation, and Partnership (including LLC) tax return.

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 will focus on regulatory requirements, optimal processes and define the difference in collaboration with both internal and external physician advisor roles. It will also discuss the role of the physician advisor and staffing needs to implement this important role.

This webinar will detail a step-by-step procedure on how to write a practical, effective and compliant Standard Operating Procedures (SOPs), review and revise SOPs and maintain compliance over the course of the SOP life-time.

This training on BSA compliance will help you understand the concept of tax evasion and tax fraud and the difference between the two. Learn the best practices to identify tax fraud and how to report suspicious activity.

In this webinar you will learn how to determine the Root Cause origin of a problem. You will learn a specific set of steps, with associated tools, to find the primary cause of the problem, so that you can prevent occurrences.

This webinar will identify the key stakeholders needed for effective interdisciplinary rounds. It will review the best practice rounding processes including scripting and time management.

This webinar will provide an in-depth understanding of the Federal False Claims Act, Federal Anti-Kickback and Stark laws, and discuss how marketing activities can trigger either or both.