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  • 1 Request Info

    6-Hour Virtual Seminar on Combination Products

    This seminar provides Professionals working in this area with: A thorough understanding of the complexities involved Covers all the relevant regulations and guidelines Gives real life examples of how to register and maintain various types of combination products Interfaces: Change Management and LCM Compliant safety reporting for combination products Documentation requirements and interfacing
  • 2 Request Info

    6-Hour Virtual Seminar - Cracking the Code to Healthcare Billing, Coding and Reimbursement

    This course covers the fundamentals of medical billing, coding, and reimbursement by explaining how all of these components work together. Emphasis will be placed on the practical application of the latest industry knowledge and standards, with the goal of helping those who work with medical claims and claims data stay ahead of the game. Participants will learn about the following: The claim flow process from registration through adjudication and payment How physicians and hospitals set and manage charges Critical data elements on the two major claim forms and what they mean How and why the major coding systems are utilized How various reimbursement methods are used by payors
  • 3 Request Info

    6-Hour Virtual Seminar - Batch Record Review and Product Release

    Overview 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.
  • 4 Request Info

    6-Hour Virtual Seminar on Combination Products

    Overview This seminar provides Professionals working in this area with: A thorough understanding of the complexities involved Covers all the relevant regulations and guidelines Gives real life examples of how to register and maintain various types of combination products Interfaces: Change Management and LCM Compliant safety reporting for combination products Documentation requirements and interfacing
  • 5 Request Info

    Biosafety And Blood-Borne Pathogen Safety In The Lab

    Overview: This webinar will provide you with the regulatory framework and recommended guidelines, risk assessment for biological materials, structure of a robust biosafety program and on how to train employees exposed to biological hazards. Why you should Attend: This webinar will review how best to approach biosafety and implement an effective management program for blood borne infections, safety and health, laboratory safety, infectious material and blood infection. If you work in a laboratory exposed to viruses or bacteria that are biological hazards and are searching for a better way to manage your Biosafety program, this webinar will help give you the framework to set up a successful management policy.
  • 6 Request Info

    HIPAA Breach - or Not? How to Find Out & What to Do

    Overview: This webinar explains the inter-connected Breach Notification Rule requirements of Covered Entities and Business Associates when a Business Associate or Subcontractor Business Associate suffers a Breach. And it covers the special, more restrictive compliance requirements when a Business Associate or Subcontractor is an Agent under the Federal Common Law of Agency - including how to avoid creating an Agency relationship by mistake. This webinar for HIPAA Covered Entities and Business Associates explains the 5 Steps of HIPAA Breach. Notification Rule Compliance. They are: Potential Breach Investigation How to recognize a Potential Breach The information you need to gather 5 Key Questions that can confirm no Breach occurred
  • 7 Request Info

    3-Hour Virtual Seminar on The Interface Between Medicare and Medicaid

    Overview: Recent cases and/or enforcement actions involving the Federal Civil False Claims Act (FCA) as well as the Medicare-Medicaid Anti-Kickback Statute (AKS) and/or Federal Physician Self Referral Law (Stark II) raise serious concerns regarding compliance issues with the hospital, physician practices, and other healthcare entities. Recoveries under the FCA are at an all-time high, and the percentage of actions involving healthcare organizations has been increasing at exponential rates. Why you should Attend: This session is designed for health care executives, physicians and other health care providers who participate in and receive remuneration from Medicare, Medicaid, and other federal health care programs such as Tricare.
  • 8 Request Info

    The Anti-Kickback Statute: Paying for Referrals is a Bad Idea

    Overview: The session will provide an overview of the Anti-Kickback Statute (AKS) and review what it prohibits, as well as review the Statute's available safe harbors. It will also show how violation of the AKS can raise FCA concerns, and it will provide an assessment of enforcement activities, showing how participants may be at risk. In addition, the session will review recent cases and show how they potentially impact participants. We will provide an in-depth review of the AKS, focusing on what is prohibited under the Act and what the exceptions are. We will also review the case law, particularly the early case law that sets the stage and basis for how the courts interpret the law. Since one of the exceptions to enforcement under the Act is regulations promulgated by the Secretary, the "safe harbors," payment practices that will not be subject to criminal prosecution and that will not provide a basis for civil monetary penalties.
  • 9 Request Info

    Dealing with the Disruptive Practitioner in a Legally Compliant Manner

    Overview: 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. Why you should Attend: 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.
  • 10 Request Info

    Project Management in Healthcare

    Overview: While the universal language defined by the PMI does not always translate to the jargon regularly used by healthcare professionals, the majority of work performed by most healthcare professionals includes, or is completed defined by, project-specific work. By attending this webinar, you will be able to answer: Why the field of Project Management deserves its own designation? How one can become a credentialed PM? When does it makes sense to prepare for the PMP exam or to recruit a more seasoned PMP? What are the shortcomings of the PMP, specific to Healthcare?
  • 11 Request Info

    Physician Employment Agreements: Items to Consider

    Overview: We will review the various elements of the physician employment agreement, focusing on the pitfalls and the problems that can develop when the agreement does not clearly define the relationship, and/or when the parties do not fully understand what is being agreed to,Such items as term and termination, termination for cause, duties of the physician, call, non-compete, and compensation are all items that should be clearly set out in the agreement and fully understood by the parties. Why you should Attend: Formal written contracts establish the legal relationship between the parties; they state the terms and conditions of that relationship and the rights and obligations of each party. They confirm the intentions and relationships of the parties as they enter into this relationship, and they eliminate uncertainties regarding mutual rights, obligations, and relationships.
  • 12 Request Info

    HIPAA Fundraising: What you Need to Know, What you Need to Do

    Overview: In 2013, The US Department of Health and Human Services made major changes to rules implementing The Health Insurance and Portability Act of 1996 (HIPAA) and Health Information Technology for Economic and Clinical Health Act of 2003 (HITECH). Among the many areas impacted by these rules (billing, marketing, research, IT security, etc.) is fund raising. The amendments significantly modify the methods and practice that hospitals, their institutionally related foundations, and other healthcare charities may or must employ when using ANY patient or client information for fund raising.
  • 13 Request Info

    HIPAA Waivers During COVID-19

    Overview: This webinar will review the sections of the HIPAA privacy rule that under the federal emergency for COVID-19 declared in March will be under a waiver issued by the OCR and penalties will be waived. HIPAA, as a whole, is still being monitored however and the webinar will also include those areas that are still being enforced and what you need know, whether you are a covered entity or a business associate. Why you should Attend: There are many portions of the HIPAA Privacy Rule in which enforcement by the Office of Civil Rights (OCR) are going to be waived. This Webinar will explain these waivers by the OCR and how they may affect covered entities and business associates.
  • 14 Request Info

    Strategic Planning and Execution Amidst the Coronavirus: The 1-2-3 Year Plan for Enterprise Success

    Overview: Before the Coronavirus (COVID-19) appeared, has your workforce been largely office-based? Is this the first time you and your team have been working 100% virtually? If so, then this Webinar is for you! As enterprises have been growing far and wide, often international in scope, we find ourselves as executives and managers with our talent spread farther and farther, often at dozens and hundreds of locations. How do we 'get a better handle' on all this?
  • 15 Request Info

    6-Hour Virtual Seminar - Medical Claims Boot Camp - Cracking the Code to Healthcare Billing, Coding and Reimbursement

    This course covers the fundamentals of medical billing, coding, and reimbursement by explaining how all of these components work together. Emphasis will be placed on the practical application of the latest industry knowledge and standards, with the goal of helping those who work with medical claims and claims data stay ahead of the game. Participants will learn about the following: The claim flow process from registration through adjudication and payment How physicians and hospitals set and manage charges Critical data elements on the two major claim forms and what they mean How and why the major coding systems are utilized How various reimbursement methods are used by payors
  • 16 Request Info

    6-Hour Virtual Seminar on EU Regulatory Affairs strategy during development of medicinal products

    The main document from a regulatory perspective in the development of a medicinal product is the regulatory plan. In this Seminar it is explained how to write the regulatory plan, and which aspects to consider. The regulatory plan describes the regulatory strategy, as well as pricing and reimbursement issues in your development. Orphan Medicinal Products will be discussed, and the advantages of having a status as an orphan medicinal product will be explained. Incentives for the development of orphan medicinal products have been available in the United States of America since 1983 and in Japan since 1993, and also the EU offers a range of incentives to encourage the development of these medicines.
  • 17 Request Info

    6-Hour Virtual Seminar on Biostatistics for the Non-Statistician

    Statistics is a useful decision making tool in the clinical research arena. When working in a field where a p-value can determine the next steps on development of a drug or procedure, it is imperative that decision makers understand the theory and application of statistics.
  • 18 Request Info

    6-Hour Virtual Seminar on Combination Products

    This seminar provides Professionals working in this area with: A thorough understanding of the complexities involved Covers all the relevant regulations and guidelines Gives real life examples of how to register and maintain various types of combination products Interfaces: Change Management and LCM Compliant safety reporting for combination products Documentation requirements and interfacing
  • 19 Request Info

    Key Elements in Managing and Maintaining Your Credit Administration and Credit Policy

    Overview: This session by Dev Strischek is intended to provide guidance on how to develop and maintain a Credit Administration (CA) function that will provide guidance to anyone involved in the credit function of the bank. The session also highlights the safeguards to manage the bank's loan portfolio in a safe and sound manner.
  • 20 Request Info

    Dietary Supplements CGMPS - 21 CFR 111 Compliance

    Overview: 21 CFR part 111 ("the DS CGMP rule") requires persons who manufacture, package, label, or hold a dietary supplement to establish and follow current good manufacturing practice-the CGMPs. This is to ensure the quality of the dietary supplement and to ensure that the dietary supplement is packaged and labeled as specified in the master manufacturing record. This webinar will discuss basic Dietary Supplement CGMP of Part 111 and related requirements, to include: Quality Management System / QA / QC Personnel, Facilities, Equipment Software controls Production and Process Controls Holding and Distribution Complaints and Returns Records