Compliance Training Webinars for Regulated Industries

This program will review the compliance issues that most greatly impact your practice such as the 2-midnight rule, the NOTICE Act, HINNs, the important message from Medicare and others. The Joint Commission is now monitoring these issues when they have deemed status from Medicare, so your compliance is critical to a good Joint Commission survey outcome. This program will help you to identify where you may have compliance practice gaps as well as how to fix them.

This training program will discuss the concept and application of uncertainty of measurement (MU) as required by ISO/IEC Standard 17025:2005 for laboratory accreditation, from a practical microbiological perspective, using unambiguous language and useful examples.

This webinar will review the regulatory requirements for investigating an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed. A detailed flow chart will be used to help the attendees clearly understand the steps and the order in which they are to be performed. The structure of an Investigation report which properly documents the investigation will be discussed.

This webinar will discuss the latest global medical device design controls requirements for software in a medical device (SiMD) and software as a medical device (SaMD). Each requirement pulled from U.S. and global standards and guidance (e.g. IEC 62304, IEC 82304, IMDRF SaMD Guidance, AAMI TIR45) will be explored to fashion a complete picture of activities, document content, and dependencies across a variety of lifecycle development models. The session will also include special topics such as evolving cybersecurity requirements, the relationship of software design controls to non-medical device applications, and proposed regulatory frameworks for AI/ML systems.

The meanings and regulatory requirements of the terms “verification” and “validation” are often confusing to engineers and even some regulatory professionals. FDA regulations as well as European standards such as ISO 13485:2003 require both verification & validation documentation throughout these regulations and standards. The terms apply to design control, process control and others. This presentation will define and explain the differences (& similarities) in these terms and how they apply to regulated industries as well as the consequences of poor adherence.

Discrimination continues to be a problem in the workplace even with existing and developing regulations to train employees and managers against engaging in such behavior. The obligation to conduct a sound and thorough investigation by an appropriate investigator is mostly understood, but practitioners need to do that actual work. This course is designed to provide HR practitioners of all levels with a step-by-step process for conducting discrimination investigations in the work environment that will protect employees and the company as well.

This training will cover several recommendations to improve the hospital’s due diligence when administering and dispensing narcotic drugs in a hospital setting and what steps to take to detect and prevent the illicit use or diversion.

This course will cover validation essentials for medical device manufacturers. Attendees will learn about what processes needed to be validated and what steps you need to take to validate processes. You’ll learn the essentials of validation planning, protocol writing, and change management. We’ll cover the steps of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) including tips and best practices.

This training will cover compliance requirements for running clinical trials in pediatrics, particularly in the EU to comply with the EU ethical considerations guidance for running clinical trials in pediatrics.

Learn when and how you must compensate employees for travel time. Ensure you comply with the requirements under the Portal Act. Get an update on IRS travel expense documentation requirements. Learn about employer liability for accidents of traveling employees. Clearly define when employee meals are 100% deductible and when they are only 50% deductible. Understand the limitations when personal and business travel and entertainment are mixed. Ensure your records will stand the scrutiny of a compensation or tax audit.

Dr. Davis describes important directions and core principles of selected frameworks. He also links these guidelines and principles to relevant practices. The principles outlined in this session reflect ISACA defined governance system themes: (1) meeting stakeholder needs (2) enterprise end-to-end coverage, (3) organizational customization (4) dynamic homeostasis, (5) enabling a holistic approach, and (6) separating governance from management.

In this webinar, we will explore the challenges employers now face in managing employee marijuana use. We will, also discuss applicable laws (both statutes and cases) addressing this subject, analyze recent court cases. The laws, of course vary by state. You will receive an overview of where many of the different states are currently holding with respect to medical and recreational marijuana and employer’s rights and obligations.

Missteps in handling sensitive employee issues could result in your organization writing a check with a lot of zeros on it. How companies investigate potential misconduct can affect the company’s reputation as well as its bottom line. Cultural and generational diversity is changing the landscape of the US workforce. That diversity can become fuel for all types of litigation. Understanding how to effectively conduct workplace investigations can greatly reduce the chances of your organization being sued.

Despite growing available information and training materials about the critical value of Software Asset Management, many organizations still find themselves unprepared for a software license compliance audit. A software license audit can cause severe disruption and takes time and resource away from business as usual. In this webinar, Dr. Davis will discuss the different approaches to achieving software license contracting compliance.

This course provides medical device/pharmaceutical professionals with the information they need to prepare for and manage any type of FDA inspection. This course provides the rationale, strategies and flow on how to plan for an inspection, the inspection process and approach, and which company roles should be assigned for these types of inspections, among other related topics.

Government laws and regulations usually require an entity’s management to design, implement, and maintain a control system. However, controls existence and effectiveness verification are commonly an external and internal statutory audit responsibility. Auditors that conduct entity compliance attestation engagements focus on examining, reviewing, or performing agreed-upon procedures regarding a subject matter or assertion about a subject matter and reporting evidentially supported results.

All public water systems (PWSs), except aircraft PWSs subject to the Aircraft Drinking Water Rule (ADWR) (40 CFR 141 Subpart X), must comply with the RTCR as of April 1, 2016. Are you in compliance 5 years later? In this webinar, learn what do you need to do to be in compliance?

The ability to present articulately to management, to the customer, or a non-tech audience can significantly enhance your credibility. Delivering engaging presentations at work or professional events is a way to share your ideas and gain a reputation as a valued employee and an expert in your field.

Cannabis, or marijuana, is illegal under federal law. However, at least 30 states and the District of Columbia have legalized marijuana for medicinal use and nine states, soon to be more, have legalized it for recreational use. This conflict presents a unique challenge to employers. At the same time, the illegal use of legal prescription drugs has reached, in the words of the Center for Disease Control, epidemic status. What do employers need to know about this new drug environment at work? What policies and procedures need to be addressed? How do employers comply with the new regulations? What about my pre-employment drug testing program? These questions and others will be answered by this webinar.

A key component of building a clinical research finance team is creating a staffing model that will support the health system’s clinical research portfolio. This course focuses on key metrics and KPIs to help attendees develop a staffing model for their organization.