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  • 1 Request Info

    15- Minute Expert Adult Patient Assessments: Practical Strategies, Tips, and Updates for Health Care Professionals

  • 2 Request Info

    The Requirements and Responsibilities of a HIPAA Security/Privacy Officer

    Discussions, presentation, and webinars regarding HIPAA regulations are usually addressed from the perspective of what the regulations entail, the necessity of compliance with the regulations, and the consequences of willful neglect or non-compliance. A great deal of attention is given to the details of new requirements in the regulations when they are published. It is appropriate to address these topics in detail, because they usually require clarification. This presentation addresses HIPAA regulations from a different perspective – from a personal perspective – from the perspective of the person in charge of moving an organization or facility out of “willful neglect” and toward full compliance with HIPAA. The by-product of this presentation will be both an understanding of, and a detailed job description for, a position mandated in the regulations – the HIPAA Security/Privacy Officer.
  • 3 Request Info

    Avoiding Critical R&D Formulation/Drug Delivery Errors

    We hopefully learn from our mistakes. But, it is far better to learn from other people’s errors and avoid them in the first place. In nearly 40 years of R&D in the pharmaceutical industry, I’ve made--and seen-- some doozies— technical errors, miscommunications, strategic planning oversights, and quite a few “political” blunders. Many, if not all, were preventable. All were costly! For example, over a multi-year period, our manufacturing plant had an occasional release-assay failure, for commercial heparin in intravenous bags. The plant did not consider it a serious problem because re-testing, with a larger sample size, nearly always was successful; the problem was attributed to assay-error and most of those lots were released. Suddenly, every batch failed. It was only then, that the Manufacturing Group got our R&D involved.
  • 4 Request Info

    Auditing Physician Contracts Under the New Stark Rules

    In this session Mr. Wolfe will provide an overview of the Stark Law, including its 2016 changes. He will also discuss best practices for auditing physician compensation arrangements on behalf of health systems, hospitals, medical groups and physician practices. The webinar will focus on regulatory requirements, key provisions, valuation considerations and potential pitfalls that should be avoided. Healthcare reform has invigorated the government's focus on healthcare fraud, including enforcement of the Stark Law. Improper design and implementation of physician arrangements can result in penalties, denial of payments, and exclusion from federal health care programs. Thus, ensuring Stark Law compliance will be critical for medical groups, hospitals and health systems looking to manage areas of enterprise risk.
  • 5 Request Info

    TrumpCare- How to Prepare and Be a Forward Thinker for Changes in Health care Reform

    A copy of two published articles on TrumpCare will be provided. A copy of the PPT will also be provided. Now that Trump is the President-Elect and on Feb 1, 2017 will be President of the USA; what will he repeal, reform or replace with Health Care Reform? Be prepared and find out now what you should be doing in 2017. We call this TrumpCare. Learn what should be in it and learn how to offer a cost effective health plan.
  • 6 Request Info

    FDA and EMA Global labeling challenges faced in day-to-day operations

    Pharmaceutical companies must manage the process of designing and creating product labels that meet regulatory requirements. This includes product-labeling documents such as Packet Inserts (PIs), Summaries of Product Characteristics (SmPCs) and Core Data Sheets (CDSs). The large number of product strengths, dosage forms and product presentations results in a large number of labeling records that must be maintained and kept synchronized. The FDA and EMA are implementing a set of rules for the electronic submission of labeling content. The FDA labelling regulation requires companies to submit XML labeling content in Structured Product Labeling (SPL) format. The EMA labelling regulation requires companies to submit product information documents in QRD-compliant format.
  • 7 Request Info

    How to Deal With the Disruptive Practitioner

    Disruptive activity by practitioners in the hospital takes many forms. When it happens, it is important that the hospital and/or the medical staff take appropriate steps to see that it does not affect patient care or disrupt operations. Hospital executives, medical staff officers, and peer review committee members and support staff should attend to learn how to deal effectively with the disruptive practitioner. You will also learn how to prepare for the day when it becomes necessary to terminate such a practitioner’s privileges and medical staff membership. You will also gain an understanding of how to develop provisions in the medical staff bylaws to deal with the disruptive practitioner and how to develop a clear and concise policy regarding disruptive behavior. We will discuss the elements of an effective policy and the actions that should be taken to develop progressive discipline and/or sanctions that should be taken before taking action under the corrective action procedures.
  • 8 Request Info

    Effective Batch Record Review

    Most Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records. Additionally, there must be written procedures for a batch record review process that demonstrate compliance. A strong batch record review system is essential in order to properly document all critical processing parameters that go along with the production and manufacture of pharmaceuticals, biologics, medical devices, etc. This webinar will analyze each of these necessary elements of the batch record review process.
  • 9 Request Info

    2017 HIPAA Changes

    This lesson will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order as HIPAA is now fully enforced and the government is not using kid gloves any more. It will also address major changes under the Omnibus Rule, Trump administration, and any other applicable updates for 2017 and beyond.
  • 10 Request Info

    Hazard Analysis following ISO 14971

    The US FDA expects that as part of a product development Design Control Program risk management will be conducted. FDA recommends using ISO 14971 as a guide and has accepted it as a recognized standard. One of the techniques described in ISO 14971 is Hazard Analysis. This is the most powerful of the risk management techniques because it considers risks in normal operation as well as fault conditions. FMEA and FTA consider only fault conditions and are more suited as reliability tools than as product safety tools. In this ISO 14971 risk management training we will explain in detail the process of conducting a hazard analysis. The confusing terms “hazard”, hazardous situation”, “harm”, “causative event”, “ALARP”, “risk index”, “residual risk” will be explained. We will go step by step through a template for hazard analysis so that the process is clear.
  • 11 Request Info

    Countdown to MACRA: It's Time for Physicians to Pick Their Pace for 2017

    On October 14th CMS published the final rule that outlines its implementation of MACRA value-based payment reform starting in 2017. The new framework is called the Quality Payment Program. Going forward, clinicians and health care leaders need to be developing strategies so they can position their organizations for financial success under the new Quality Payment Program. Beginning in 2017, CMS will start rewarding clinicians for their delivery of high-quality patient care through one of two pathways: (1) payment of incentives for participation in Advanced Alternative Payment Models (Advanced APMs); or (2) application of a positive or negative adjustment pursuant to the clinician's performance under the new Merit-based Incentive Payment System (MIPS).
  • 12 Request Info

    Pharma Analytics – I Have All These Data, Now What Do I Do?

    We know that it takes more than a large data set and computer software to effectively solve problems. As information technology increases in capability and availability the opportunity to use data to develop and improve processes becomes even greater. Particular attention is paid to the pedigree of the data: the process that generated the data, the measurement process and the data collection process including the sampling schemes used. Also essential to success is the use of subject matter knowledge to frame the problem and assess and interpret the results of the analysis.
  • 13 Request Info

    The Most Common Coding Errors and How to Avoid Them

    There is a wealth of information outside of the CPT manual that is necessary for the coder to perform his or her job correctly. These are conceptual an organizational points that every coder must have a firm grasp of additionally we will look at some of the most common coding examples and resources for further information.
  • 14 Request Info

    Telemedicine and being Compliant

    Nearly nine out of 10 family physicians say they would use telehealth to assist in treating their patients if they were compensated for it, according to a survey conducted by the Robert Graham Center for Anthem, Inc. and the American Academy of Family Physicians. Telemedicine is a $27 dollar billion industry set to grow to more than $34 billion dollars by 2020. By next year millions of new members will have access to covered telemedicine services by commercial payers. This growing line of business creates opportunities that require coders to be ready to code these services confidently, navigate the associated rules and reimbursement issues, and understand the emerging procedures associated with telemedicine. This one hour conference provides the listener with these coding insights and more!
  • 15 Request Info

    Inclusion of LGBT Employees in Healthcare: Navigating Policies, Procedures, and Practices

    Healthcare is a unique culture dealing with vulnerable patients and employees committed to quality patient care. However, research states that LGBT patients are treated in a more abusive manner than straight patients. How does the misconduct to LGBT patients impact your LGBT employees? We know that healthcare does employ LGBT people. How does your organization prevent sexual discrimination at healthcare? Do you intentionally recruit the LGBT community as employees in your healthcare organization? Do you know how to assist a transgender employee in transitioning? Does your marketing for employees (and patients) include images representing the LGBT community? Healthcare organizations have made progress towards LGBT equality yet LGBT workers still go to work every day with fear that they might lose their jobs because of whom they love and who they are. This webinar will help you to design, develop, and implement effective strategies to prevent LGBT discrimination in the workplace
  • 16 Request Info

    What Employers Can Implement to Minimize the Risk of Workplace Violence

    Workplace Violence in your workplace; the consequences are many, unpredictable, and can be severe. Injury or death of employees, customers, and/or visitors from workplace violence, resulting in lawsuits, property damage, increased insurance premiums, OSHA enforcement actions, increases employee turnover and reduced community trust.
  • 17 Request Info

    Risk Management, Professional Codes of Ethics, and Ethical Practice for Mental Health Professionals: A Comprehensive Guide to Navigating Ethics and La

    Nowhere but in mental health are there more diverse clinicians providing the same or similar services of counselling and therapy. Various codes of ethics and state laws intersect to govern each mental health care practitioner. Mental health practitioners are faced with a variety of high risk management process and legal situations. These events can expose clinicians to liability, lawsuits, and complaints to state licensing boards. This webinar surveys ethics and law for mental health practitioners. Learn about ethical practices, risk management, and professional codes of ethics. Mental health professionals are faced with a variety of life or death, high risk, legal situations. These events can expose clinicians to liability, lawsuits, and complaints to state licensing boards. For example, dual relationships and standard of care are two of the most common issues associated with the sanctioning of mental health practitioners.
  • 18 Request Info

    Effective Environmental Monitoring Program: Best Practices in Bio/Pharmaceutical Production

    Recent consent decrees have highlighted the importance that the FDA has put on environmental monitoring as a way of verifying control of the operational environment, along with the expectations when sampling methods yield positive results. Whether environmental monitoring is used simply to verify a state of cleanliness within a packaging area or during the production of sterile products, the assurance for sterility or area cleanliness is dependent not only on cleaning and sterilization methods used, but also with the control of the environment in which they are produced.
  • 19 Request Info

    Customs-Trade Partnership Against Terrorism (C-TPAT) Supply Chain Security and Compliance for Regulated Industries

    The Customs-Trade Partnership Against Terrorism (C-TPAT) is a voluntary supply chain security program led by U.S. Customs and Border Protection (CBP). It is intended to improve the security of supply chains of private enterprises against the threat of terrorism. The program was launched in November 2001, with seven large U.S. companies as the initial participants. By the end of 2014, more than 10,000 members joined the effort. More than 4300 importers in the program account for more than half of the value of all merchandise imported into the U.S. C-TPAT certification can be attained by companies who seek to be considered low risk, enabling their cargo to be processed in an expedited manner with fewer Customs examinations. The certification involves a documented process for determining and mitigating risk throughout a company’s international supply chain. The program is voluntary, but affords those participating in it a huge advantage in terms of international trade.
  • 20 Request Info

    Qualification of Clean Compressed Air Systems for cGMP Manufacturing

    In the pharmaceutical industry, compressed air is used for a number of production and packaging applications, including blowing off and drying bottles prior to filling, conveying pills, providing air for pneumatically controlled valves and cylinders, as well as breathing air systems. Each of these applications requires a different level of air quality and a different combination of air treatment to meet the needed quality. Because the uses of compressed air within the industry vary so greatly, there is no set standard in place that every process must adhere to. While the FDA may not have issued a directive for compressed air quality in the pharmaceutical industry, there is still a resource available to help select appropriate air treatment components for a compressed air system. A typical pharmaceutical plant might have a compressed air specification of ISO Quality Class 1.2.1—Class 1 for Solids and Dust, Class 2 for Humidity and Liquid Water, and Class 1 for Oil.