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  • 1 Request Info

    Webinar On Hospital Systems:Medical Staff Issues

    Overview: This webinar addresses the medical staff issues arising when hospitals merge or are acquired by healthcare systems.Change in hospital ownership affects governance, including medical staff governance. The existing medical staff bylaws, rules and regulations and policies may be replaced as a result. Already established systems also create conflicts as system-wide documents may not fit all medical staffs in that system hospitals.The complication of recent changes in Medicare Conditions of Participation to allow systems to unify medical staffs will also be analyzed. Why should you Attend: Hospitals are merging or being acquired continuously by expanding healthcare systems.Merging medical staffs is no less complicated than the financial side of system growth. Planning and preparation can guard against combined medical staff conflicts and liability.
  • 2 Request Info

    Take the Fear out of HIPAA - Basic Step-by-Step Compliance

    Overview: The HIPAA Rules are frequently misunderstood and inadvertently violated. However, HIPAA Rules are easy to follow, step-by-step, when you know the steps. This session will explain exactly how a health care provider's designated HIPAA Compliance Official can find the right steps for each HIPAA compliance topic and how the health care provider can review and be assured the practice is up to date and in compliance with the HIPAA Rules. Why should you Attend: HIPAA can be complicated but this session provides practical solutions and answers to everyday problems you can understand. This session covers the HIPAA Privacy, Security, Breach Notification and Enforcement Rule compliance requirements for health care providers in plain language. Using practical, everyday examples Step-by-Step, with PowerPoint presentations and interactive exercises
  • 3 Request Info

    Structuring and Auditing Non-Physician Practitioner Arrangements Under the Anti-Kickback and Stark Laws

    Overview: In this session Mr. Wolfe will provide an overview of the Stark Law, including its 2016 changes. He will also discuss best practices for negotiating and drafting NPP 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. Why should you Attend: Prior to moving forward with any NPP arrangements, the parties should carefully evaluate whether the proposed structure and financial terms support compliance with Stark's technical requirements and key tenets of defensibility so they will be prepared to mount a defense in the event the lease is ever challenged. This webinar will focus on the Stark Law's underlying technical requirements and key tenets of defensibility as they apply to NPP arrangements.
  • 4 Request Info

    Compensating Employed Physicians: Key Stark Law Considerations

    Overview: In this session Mr. Wolfe will provide an overview of the Stark Law, including its recent changes. He will also discuss best practices for structuring, negotiating physician employment agreements. The webinar will focus on regulatory requirements, key provisions, valuation considerations and potential pitfalls that should be avoided. Why should you Attend: As health care organizations and physicians develop their employment arrangements, they must ensure the employment and compensation structures are defensible under the Stark Law. In this webinar Mr. Wolfe will describe how to evaluate whether a proposed employment structure and financial terms will support compliance with Stark's technical requirements and key tenets of defensibility to manage risk.
  • 5 Request Info

    Key Legal Considerations When Redesigning Your Physician Compensation Plans

    Overview: In this session Mr. Wolfe will provide an overview of the Stark Law, including its technical requirements and key tenets of defensibility. He will also discuss best practices for structuring evaluating and structuring new compensation models. The webinar will focus on regulatory requirements, key provisions, valuation considerations and potential pitfalls that should be avoided. Why should you Attend: As health care organizations redesign their compensation plans, they must be sure the process they follow and the models the new models they develop are defensible under the Stark Law. In this webinar Mr. Wolfe will discuss developing best practices and how to evaluate whether a new compensation model is compliant with Stark's technical requirements and key tenets of defensibility.
  • 6 Request Info

    Developing a Physician Compensation Strategy Focused on Quality and Value

    Overview: In this session Mr. Wolfe will provide a straight-forward, practical explanation of developing concepts, including the quality and value metrics into new federal health care programs and commercial payment systems, new delivery models, what providers can be doing to develop a value-based strategy, and the application of the Stark Law and other fraud and abuse laws to new models aimed at population health, quality of care and cost control. Mastering these concepts will be a must for health care executives looking to position their organizations for success in this new value-based world. Why should you Attend: Medicare, Medicaid and private payors are looking to accelerate the transition from volume to value and population health through targeted incentives.
  • 7 Request Info

    HIPAA Cyber Crime - How to Prevent, Prepare, Respond and Recover

    Overview: This webinar for HIPAA Covered Entities and Business Associates explains how to use the HIPAA Rules to Prevent, Prepare, Respond and Recover from Cyber Attacks. Why should you Attend: Cyber Threats to the Security of Health Information are at Crisis levels. The latest threats are caused by two security flaws called "Meltdown" and "Spectre" in nearly all "chips" - microprocessors installed in electronic devices like computers, smartphones and tablets. Windows, Linux, iOS, MacOS, tvOS, Android and nearly all operating systems are affected by these vulnerabilities. Meltdown and Spectre, could allow hackers to lift passwords, photos, documents and other data from electronic devices and cloud computing services used by the entire Healthcare Industry. Meltdown and Spectre add to a list of Cyber-Threats that, today, are more dangerous to the Healthcare Industry like Ransomware.
  • 8 Request Info

    Scoop-Top Targets of Fed HIPAA Enforcers & Simple Steps to Take Control

    Overview: This webinar for HIPAA Covered Entities and Business Associates will identify the top OCR HIPAA enforcement priorities for 2018 and explain simply how you can master HIPAA compliance requirements for each enforcement priority. Why should you Attend: HIPAA Compliance is in crisis throughout the United States. The Office for Civil Rights (OCR), the HIPAA enforcement arm of the U. S. Department of Health and Human Services has just announced results of its recent HIPAA Compliance Audits of Covered Entities (CEs). The audited CEs represented a cross-section of all types and sizes throughout the nation. All knew they were on a shortlist to be audited and had access well in advance to the questions they would be asked and documents they would be required to produce. Nevertheless, OCR found 94% (59 of 63) of CEs to be inadequate or worse in Risk Management compliance and 87% (55 of 63) to be inadequate or worse in Risk Analysis compliance.
  • 9 Request Info

    Managing Your FDA Inspection: Before, During and After

    FDA's inspection program follows well-established procedures and conducts the inspections with as much consistency as possible. FDA trains its investigators from day one. During the first six months, they attend extensive classroom and hands on training. FDA investigators learn basic skills. As time goes on, special training is given and the field staff use detailed reference materials to guide their thinking, actions, decisions and conclusions. If you understand FDA's management of its investigators and inspectional process, you can keep your establishment ahead of a needless regulatory disaster. FDA conducts inspections with standard operating procedures and detailed information on how to handle almost any situation the FDA investigator may face. Click to Continue Reading: https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901411SEMINAR?trainingregistry-April-2018-SEO
  • 10 Request Info

    Tougher Import Rules for FDA Imports in 2018

    FDA and the Customs and Border Patrol Service (CBP) have become increasingly sophisticated and equally demanding in the submission of import information and adherence to government procedures. Firms that fail to understand and properly execute an import and export program find their shipments delayed, detained or refused. As of December 2016, FDA and CBP officially implemented the Automated Commercial Environment (ACE) entry filing system. You either meet ACE requirements or face entry refusals and monetary penalties of up to $10,000 per offense. Click to Continue Reading: https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901402SEMINAR?trainingregistry-April-2018-SEO
  • 11 Request Info

    A Risk Based Strategy for the Development & Validation of and Validation of Analytical Methods with a QbD Approach

    Following the initial development, the steps further continues thru optimization and subsequently to Validation, leading to the understanding of Validation Parameters and their generic definitions. Guidance from EP, USP, ICH Q2 (R)1, AOAC etc. will be discussed. The presentation continually builds on from a conceptual level to practical applications leading to data handling, Data Integrity, Validation Protocol and other documentation, vis-a-vis Regulatory requirements. Discussions provide extensive guidance for preparing Methods Validation Protocols for the various stages of regulatory submissions, e.g. IND, NDA, ANDA, PAI, CMC etc. Various aspects of Laboratory Controls (CGMP), QC procedures, SOPs that cover calibration, standardization, Qualification and Validation, will be included, along with statistical tools, SQC, SPC for processing and monitoring of analytical data. Strategies for the development Stability indicating assays will be touched along ...
  • 12 Request Info

    Evolution of the Quality Management System - How to go from Surviving to Thriving

    Many companies struggle to establish and maintain a Quality Management System (QMS) that is both efficient and effective. An ineffective QMS leads to disastrous consequences such as medical device reports, recalls, 483s, and warning letters. An ineffective QMS can result in serious consequences for your customers leading to dissatisfaction, serious injury, or even death. It is imperative that medical device companies can effectively establish a QMS. And an inefficient QMS results in wasted time, money, and missed opportunities. In this 2-day seminar, we will use lecture, exercises, and discuss to learn the fundamentals of a Quality Management System and how you can take your program from surviving to thriving. A thriving QMS can help you achieve your compliance objectives and improve product quality, leading to higher customer satisfaction and business results.
  • 13 Request Info

    HIPAA Training for the Compliance Officer 2018

    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 and any other applicable updates for 2018 and beyond. There are an enormous amount of issues and risks for covered entities and business associates these days. I will speak on specific experiences from over 17 years of experience in working as an outsourced compliance auditor, expert witness on multiple HIPAA cases, and thoroughly explain how patients are now able to get cash remedies for wrongful disclosures of private health information. Click to Continue Reading: https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901510SEMINAR?trainingregistry-April-2018-SEO
  • 14 Request Info

    HIPAA Compliance Requirements | HIPAA Privacy Security 2018

    Being the HIPAA Security and Privacy Official involves not only ensuring you know the appropriate patient rights and controls on your uses and disclosures of protected health information, but you also have the proper policies and procedures in place. If audited or the subject of a breach investigation, you will be required to show the government you have all the necessary documentation in place for safeguarding patient Protected Health Information and indicate how you addressed all required security safeguards. This starts with the fundamentals of a HIPAA compliance program. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901516SEMINAR?trainingregistry-March-2018-SEO
  • 15 Request Info

    ISO 14971 Risk Management Training-IEC 62304 Risk Management

    Gaps, incorrect or incomplete implementation of safety functionality can delay or make the certification/approval of medical products impossible. Most activities cannot be retroactively performed since they are closely linked into the development lifecycle. Diligent, complete and correct implementation of risk management from the start of product development is therefore imperative. This course will introduce all necessary steps to design, implement and test critical medical devices in a regulatory compliant environment. This course will additionally address the software risk management and the resulting interfaces to device level risk management. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901456SEMINAR?trainingregistry-March-2018-SEO
  • 16 Request Info

    IT Infrastructure Qualification Plan | Information Technology 2018

    GxP Regulated companies are dependent on validated GxP computerized applications to conduct their day to day operations. These applications are, in turn, depended upon a qualified infrastructure that can be relied upon to provide control and regulatory compliance. The consequences of the IT Infrastructure being out of compliance can result in the failure of an entire site or geographic region being brought to a standstill while the compliance issue is resolved. It can also result in regulatory citations during a regulatory inspection as both the infrastructure be out of compliance and also cause the computerized applications that are dependent on it to be out of compliance. Effective IT Infrastructure Qualification on the other hand, confers the following benefits. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901384SEMINAR?trainingregistry-March-2018-SEO
  • 17 Request Info

    Supplier Management Solutions | Medical Device Manufacturers

    Supplier selection and management is one of the critical issues for medical device manufacturers. Suppliers provide materials and services to the device manufacturer, which means that they can be critical to performance and delivery of your device. Neither the FDA nor your notified body regulates your suppliers (with a few exceptions). They expect you to have an effective process to ensure your suppliers perform in the regulatory environment. How well do you understand the requirements for supplier management? Could you pass a regulatory audit or inspection without any issues? Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901480SEMINAR?trainingregistry-March-2018-SEO
  • 18 Request Info

    21 CFR Part 11 Compliance Checklist- FDA Software Validation

    This interactive two-day course explores proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments. Many companies are outsourcing IT resources and getting involved with Software as a Service (SaaS) and cloud computing. These vendors are not regulated and therefore regulated companies must ensure compliance for both infrastructure qualification and computer system validation. It is the regulated company that wants to avoid FDA form 483s and warning letters. The seminar is intended for regulated companies, software vendors, and SaaS/Cloud providers. The instructor addresses the latest computer system industry standards for data security, data transfer, audit trails, electronic records and signatures, software validation, and computer system validation. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901525SEMINAR?trainingregistry-March-2018-SEO
  • 19 Request Info

    HIPAA Risk Assessment Checklist | HIPAA Compliance Training 2018

    The first presentation explains the history of HIPAA, why it came to 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. At the end of these presentations there will be a workshop to demonstrate how to use these tools. The second session describes what a Risk Assessment is and how to perform the risk assessment. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901426SEMINAR?trainingregistry-March-2018-SEO
  • 20 Request Info

    Regulatory Requirements Cleaning Validation | FDA Guidelines 2018

    This 2 day course will cover practical guidance on cleaning validation regulatory compliance, in conjunction with, risk-based, reasonable and informed decision making and activity planning. This two day interactive course will cover fundamental principles of a cleaning validation program, exploring such concepts as the determination of residues to be targeted, selection of analytical and sampling methods, determination of appropriate limits in various pharmaceutical and biotechnology processes, and establishment of scientific rationales acceptable to regulatory inspectors. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901285SEMINAR?trainingregistry-March-2018-SEO