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Courses

  • 101 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
  • 102 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
  • 103 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
  • 104 Request Info

    Statistics for Non-Statisticians Course | Biostatistics Boston 2018

    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. Many statistical softwares are now available to professionals. However, these softwares were developed for statisticians and can often be daunting to non-statisticians. How do you know if you are pressing the right key, let alone performing the best test? This seminar provides a non-mathematical introduction to biostatistics and is designed for non-statisticians. And it will benefit professionals who must understand and work with study design and interpretation of findings in a clinical or biotechnology setting. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901561SEMINAR?trainingregistry-March-2018-SEO
  • 105 Request Info

    Drug Products for Clinical Trials | FDA Approved Drugs List 2018

    In January 2006, FDA issued a final rule which specified that most pharmaceutical products (including biologics) produced for use in Phase I clinical trial studies were exempted from complying with GMP requirements, as defined in 21 CFR Part 211 under 21 CFR 210.2(c). Section 501(a)(2)(B) of the FD&C Act requires drugs, including IND products, to comply with cGMPs or if they are not manufactured in compliance with cGMPs, they are deemed adulterated. Based on this statutory requirement for manufacturers to follow GMPs, FDA issued cGMP regulations for drug and biological products in the Code of Federal Regulations (in 21 CFR parts 210 and 211). Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901549SEMINAR?trainingregistry-March-2018-SEO
  • 106 Request Info

    What is 21 CFR Compliance | 21 CFR Part 11 Regulations 2018

    Computer Systems Validation (CSV) also known as Software Validation is all-pervasive in the Life Sciences Industry. It is a requirement of all the predicate rules, as well as 21 CFR 11 and Annex 11. However, unless one knows how to implement CSV, it is often very hard to detect the requirement for CSV, and very hard to determine what needs to be done, to meet domestic and / or international regulations or business continuity requirements. In addition, the FDA has stepped up 21 CFR 11 inspections that include CSV. This course will build on the Validation and 21 CFR 11 Compliance Basic Course, to give hands on experience on executing on the computer systems validation of a system, and to discuss related activities such as Validation Master Plan, Infrastructure Qualification, Project Management for Validation and Validation of Test Tools Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901540SEMINAR?trainingregistry-March-2018-SEO
  • 107 Request Info

    What you Need to Know about HIPAA Compliance

    Being in compliance with HIPAA involves not only ensuring you provide 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 compliance review 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 understanding the fundamentals of a HIPAA compliance program.
  • 108 Request Info

    2018 Course On how to Prepare for a HIPAA Audit

    Being in compliance with HIPAA involves not only ensuring you provide 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 compliance review 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 understanding the fundamentals of a HIPAA compliance.
  • 109 Request Info

    Webinar On Texting and E-mail with Patients - Meeting Patient Requests within the HIPAA

    The session will discuss the requirements, the risks, and the issues of the increasing use of e-mail and texting for patient and provider communications and provide a road map for how to use them safely and effectively, to increase the quality of health care and patient satisfaction. In addition, the session will discuss how to be prepared for the eventuality that there is a breach, so that compliance can be assured
  • 110 Request Info

    Webinar On Conducting OSHA 300 Log Recordkeeping Training

    This course will give a comprehensive overview of what the new OSHA 300 Log Recordkeeping Reporting Requirements are so that a beginner or a seasoned EHS Professional will have confidence in knowing how to fill these out quickly and correctly. In addition, navigating the complexities of OSHA Recordkeeping can be challenging, even for the seasoned Environmental Health and Safety (EHS) Professional. A basic review of OSHA Recordkeeping will be given and site-specific case scenarios questions and answers will be addressed throughout the presentation.
  • 111 Request Info

    Webinar On HIPAA Fundraising: What You Need to Know, What You Need to Do

    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.
  • 112 Request Info

    Developing HIPAA Policies and Procedures Webinar 2018

    Being in compliance with HIPAA involves not only ensuring you provide 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. A HIPAA Risk Management plan is your overall policies and procedures manual. If audited or the subject of a compliance review you will be required to show the government you have all the necessary policy and procedure documentation in place to address all the required safeguards. If audited by HHS, being able to demonstrate HIPAA compliance will involve providing many of these policies and procedures. Having a fundamental understanding of a HIPAA compliance helps to know what is required to implement those policies and procedures.
  • 113 Request Info

    Webinar On National Practitioner Data Bank Expanded Reporting Parameters

    Hospitals must file a National Practitioner Data Bank report on any physician’s surrender of privileges if an investigation is underway. This has always been a Data Bank reporting requirement, intended to discourage plea bargains which allowed physicians to avoid being reported if they agreed to waive hearing rights. Under the new Guidebook, expanded descriptions of "investigation" and "surrender" stretch what is to be considered a reportable surrender of privileges. OPPE and FPPE and other peer review can be affected, as are physicians’ ability to make practice decisions without inadvertently tripping Data Bank reporting triggers. Medical staff bylaws and policies need to be reworked under the new Data Bank Guidebook.
  • 114 Request Info

    Webinar On 2018 CPT and HCPCS Updates

    2018 will see significant changes in each section of the CPT and HCPCS manuals. There have been over 350 code changes with the update. This hour-long presentation will navigate you through the changes per each chapter of the CPT and HCPCS manuals. This webinar will also provide the tools necessary to remain compliant and continue the revenue cycle process day one of go-live
  • 115 Request Info

    Structuring Physician Employment Agreements: Key Stark Law Considerations

    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 physician employment agreements on behalf of health systems, hospitals and medical groups. He will explain key provisions and potential pitfalls in both types of agreements.
  • 116 Request Info

    HIPAA Compliant Patient Engagement - New Rules Webinar

    This webinar focuses on HIPAA Rules for transmitting informational email and text messages to patients over an electronic communications network. You will learn: The information that makes a message subject to HIPAA The "safe harbor" - How Health Care Providers may obtain consent from patients to send PHI in unencrypted email and unencrypted text messages and not be responsible for unauthorized access to the PHI in transmission or when received by the patient What a Health Care Provider must do if a patient does not agree to receive PHI in unencrypted email or unencrypted text message The requirements for a Business Associate to be able to communicate by email or text message with a patient on behalf of a Health Care Provider How a Business Associate may protect itself from liability for violating HIPAA Rules about email and text messages in its Business Associate Agreement
  • 117 Request Info

    Webinar On 3-Hour Virtual Seminar on MACRA & MIPS - HIPAA Rules for Text Messaging & Email

    Patient Engagement is widely recognized as essential for improving the quality of healthcare in the United States. Coordination of Care through Patient Engagement is a cornerstone of MACRA and revisions of Federal healthcare payment policy. Certified Electronic Health Record Technology (CEHRT) includes secure patient portals and secure messaging. Encrypted text message and email products are available from vendors. But patients overwhelmingly choose easy-to-use unencrypted email and text messaging systems. Tens of thousands of unencrypted appointment reminders, healthcare instructions, patient satisfaction surveys, health and wellness newsletters and recall reminders are sent every day exposing Healthcare Providers to unnecessary, easily avoidable risks. HIPAA provides a simple, but little known "Safe Harbor" for Healthcare Providers that permits unencrypted email and text message transmissions to a patient.
  • 118 Request Info

    HIPAA Texting and Emailing: Do's and Don'ts

    This lesson will be going into great detail regarding you practice or business information technology and how it relates to the HIPAA Security Rule, in particular portable devices. Areas covered will be texting, email, encryption, medical messaging, voice data and risk factors as they relate to personal devices. I will uncover myths versus reality as it relates to this very enigmatic law based on over 1000 risk assessments performed as well as years of experience in dealing directly with the Office of Civil Rights HIPAA auditors. 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. More importantly I will show you how to limit those risks by simply taking proactive steps and utilizing best practices.
  • 119 Request Info

    Auditing Physician Contracts Under the New Stark Rules

    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. Health care organizations should periodically audit their existing arrangements to ensure they are compliant with Stark's technical requirements and key tenets of defensibility (e.g.fair market value, commercial reasonableness, and not taking into account designated health service referrals, etc.) in case their physician compensation arrangements are ever challenged.
  • 120 Request Info

    HIPAA Training for the Compliance Officer

    This webinar 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 all over regarding the do's and don'ts with HIPAA - I want to add clarity for compliance officers. I will uncover myths versus reality as it relates to this very enigmatic law based on over 1000 risk assessments performed as well as years of experience in dealing directly with the Office of Civil Rights HIPAA auditors.