Healthcare Laws/Reform

Overview: The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process. The FDA holds companies responsible for filing new 510(k)s when one change is major enough to impact safety / effectiveness, or when a series of lesser changes finally reach the "tipping point".

Overview: If, instead, you look deeper to figure out why the non-conformance is occurring, you can fix the underlying systems and processes that caused it. Root Cause Analysis (RCA) is a popular and often-used technique that helps people answer the question of why the non-conformance occurred in the first place.

This seminar concentrates on five areas of wage and hour law: paying exempt employees, calculating gross wages under the FLSA, deducting from an employee's wages, the nuts and bolts of physically paying employees and changing payroll frequencies. Why you should attend Join renowned payroll expert Vicki M. Lambert, CPP for this 5 and one-half hour "Boot Camp" format, Wage and Hour Training for Payroll Professionals! By knowing and understanding Wage and Hour requirements, you can help protect your company from what could be a major financial calamity. This includes not only how to do the basic math of calculating overtime (using the required FLSA method) but what hours must be paid for, what payment methods are legal in which states, how soon to pay an employee after closing out the timecard, and making sure exempt employees are paid on a "salary basis".

This 6-hour seminar will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order before the imminent audits occur. It will also address major changes under the Omnibus Rule and any other applicable updates for 2018. Areas also covered will be texting, email, encryption, medical messaging, voice data and risk factors as they relate to IT. The primary goal is to ensure everyone is well educated on what is myth and what is reality with this law, there is so much misleading information regarding the do's and don'ts with HIPAA - I want to add clarity for compliance officers and what you guys need to do and how to best implement your HIPAA program based on over 18 years of personal experience working with Federal auditors, state auditors, and corporate auditors.

The objective of this webinar is to compare and contrast between Good Laboratory Practices and Good Manufacturing practices. Why you should attend Good Laboratory Practices (GLPs), 21 CFR part 58 are not set of guidelines but they are regulations for conducting nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products such as food and color additives, human and animal drugs, medical devices for human use, biological products and electronic products that are regulated by the FDA. GLPs are enforceable by law. They do not include manufacturing of product. GLPS are for non-clinical laboratory studies in which tests article are studied in test system under laboratory conditions to determine their safety. This does not include studies utilizing human subjects, or clinical studies, or field trials on animals.

This combined DMF (Drug Master Files) and Quality Agreement training will discuss the advantages for suppliers and drug product manufacturers in developing these arrangements together. Over time, there have been several misunderstandings between supplier / contractors and pharmaceutical / biologic finished product manufacturers. The root of many of the problems lie in a lack of a suitable agreement delineating roles, responsibilities and resolution to agreement to these issues. Part of these arrangements typically involve the development, support and updating of confidential technical files (Drug Master files), which allow suppliers to protect their confidential product and process information from each and every customer and share it only with the Agency.

Overview: Listen as Mr. Wolfe examines the new changes to the Stark and Anti-Kickback Regulations. He will discuss what these changes mean and what health care leaders should be doing now to position their organizations.

Overview: One errant email or text message can cost you tens of thousands of dollars in HIPAA fines and penalties and it doesn't matter who you're communicating with: patients, staff, providers or with insurance carriers. A violation is a violation. And if you think it couldn't happen to you, think again. Text and email HIPAA violations are not always caused by what you might think. For example, you may think you are safe as long as you don't text patients - you're wrong. Many violations generally occur between providers messaging their staff. You can avoid getting hit with a HIPAA audit and violations with a few simple changes to your current processes. But you have to be able to identify the danger zones.

Overview: This 90-minute webinar will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order as HIPAA HITECH is now fully enforced with bipartisan support and the government is not using kid gloves any more.

In this webinar speaker will explain HIPAA Risk Analysis clearly and simply for staff of Covered Entities and Business Associates tasked with doing a HIPAA Risk Analysis who are not members of "the computer security community".

Overview: The EU MDR replaces the MDD and expands the requirements for conformance. The MDR contains 174 pages with 123 "Articles" in 10 "Chapters" and 17 "Annexes". In contrast the MDD has 60 pages. New requirements are added and existing requirements are expanded. The MDR is effective May 2020 leaving limited time to prepare. These new and expanded requirements will be explained. Attendees should have a reasonable understanding of FDA regulations.

Overview: Every company’s first line of defense is to develop proper screening procedures. This is one of the most critical steps for export compliance, and it’s also one of the most overlooked, especially for small business exporters. Unfortunately, it is not unusual to find that exporting companies are not even aware they need to be screening, or that they have insufficient screening operations.

Overview: This presentation will provide a baseline of information related to cloud computing which will help the attendee better understand the cloud concept, associated regulatory challenges, and suggestions for consideration when establishing a cloud based system. Why you should Attend: Cloud computing has become perhaps the hottest compliance topic related to computer validation and electronic records. The potential economic and resource advantages to using cloud based environments guarantees that management will expect that compliance strategies will be developed that will support decisions to utilize cloud environments to perform regulated activities.

Professionals are under more stress than ever evidenced by increases in demand for better services that are more efficient and thorough, higher costs, reduced staffing, and diminishing resources. Many workers are putting in longer hours and for less pay. From working overtime to simply burning the midnight oil catching up on paperwork, work industry puts a great deal of stress and fatigue on the average worker and their relationships, including family. Many professionals bear witness to workplace challenges that range from troublesome to traumatic. As a result, high stress and burnout are major hazards of any profession. This seminar focuses on understanding each of these challenges. In addition to defining and comparing these conditions, specific triggers will be explored. Participants will gain awareness of key signs and symptoms of stress and burnout, while learning how to manage stressors and their consequences.

Credit Risk Management is the function that ensures the organization is balancing its risk appetite with its risk tolerance to attain the organization’s desired credit risk objectives. This course provides guidance in how to implement and maintain the desired level of credit risk management with practical tools and techniques. Both the market and the regulatory agencies expect credit risk management to reflect the bank’s credit culture, so the class also offers direction on how to identify the organization’s credit culture and to reposition it to support the desired credit risk culture and management

Sponsors or consultants auditing labs on behalf of a pharmaceutical or biopharmaceutical company need strong tools for preparing and conducting audits.

Overview: This training program will address the common human errors and deviations related to the use of procedures. It will also offer best practices for writing SOP’s to reduce the likelihood of human errors. Why you should Attend: Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage. Procedures play a vital role in human reliability.

In this webinar, you will learn how to take your raw data, and create meaningful reports using the powerful tools in Microsoft Excel. As a business owner or manager, you have mounds and mounds of raw data transactions, and it is a monumental task to make any sense out of that data. After this webinar, you will be able to take tons of Excel data, and quickly and easily get summary reports and charts. We will start off with the basics, then, we will add sorts, filters, subtotals, grand totals, and formulas to create a great reports that summarize your data into meaningful information that will allow you to run and manage your business better.

This 6-hour webinar takes the participants through HIPAA compliance from start to compliance. The first presentation explains the history of HIPAA, why it came into being and its evolution. This covers what HIPAA is, what steps have to be performed to be HIPAA compliant and what HIPAA compliance is. It also provides definitions to key HIPAA terms, how to define a Business Associate and how to contract with Business Associates. The second part of the first presentation is an overview of how to manage the HIPAA compliance project.

Overview: Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, supervision, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrences.