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Courses

  • 81 Request Info

    HIPAA Training for the Practice Manager

    Overview: 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 2019. 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. We will go through multiple scenarios that are commonly faced by compliance officers and how to manage these situations
  • 82 Request Info

    3-Hour Virtual Seminar on HIPAA Texting and E-mailing

    Overview: This lesson will be going into great detail regarding you practice or business information technology and how it relates to the HIPAA/HITECH Security Rule and securing PHI in transmission. I will go through multiple examples and specific scenarios and also offer simple common-sense solutions. Areas covered will be texting, email, encryption, medical messaging, voice data, personal devices, and risk factors. 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 in state law, and thoroughly explain how patients are now able to get cash remedies for wrongful disclosures of private health information.
  • 83 Request Info

    Healthcare Coding, Billing and Reimbursement: An Overview

    Overview: Many people work with various aspects of healthcare coding and billing but may not understand how providers generate their claim data, how they report the data to payors, and how payors use that information to reimburse providers. This webinar provides a high-level overview of all major aspects of healthcare coding, billing, and reimbursement. We discuss key data elements of the two major claim forms (CMS-1500 and UB04) and how that information tells the story of the patient’s encounter with the provider. We review the major coding systems including CPT, HCPCS, ICD-9, ICD-10, DRG, and APC, and examine how codes in each system are assigned and the purpose of each system. We review the typical process flow for how a provider submits a claim and gets reimbursed.
  • 84 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 should you 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.
  • 85 Request Info

    HIPAA Training for the IT Manager

    Overview: This webinar will be addressing how IT managers (and HIPAA Security 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 2019. 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.
  • 86 Request Info

    Patient Engagement - HIPAA Rules for Websites

    Overview: This session will explain the HIPAA Rules for Web Sites and Social Media. The secret is - HIPAA Rules are easy to follow, step-by-step - when you know the steps. The HIPAA Rules, HHS/OCR guidance, Resolution Agreements provide a simple, easy to use blueprint using your Web Site and Social Media to engage patients and comply with HIPAA. Why should you Attend: Patient Engagement is a cornerstone of MACRA and MIPS. Communication technology offers indispensable patient engagement tools. Secure, certified technology is available. But provider Web Sites and Social Media are, by far, the engagement tools patients choose. Provider Web Sites and Social Media are inexpensive, easy to build and almost universal today. However, Patient Engagement through Web Sites and Social Media pose serious risks of violating HIPAA Privacy and Security Rules.
  • 87 Request Info

    HIPAA, Consents, and 42 CFR Part 2 - Tracking the Release of Information Under Conflicting Rules

    Overview: For much of healthcare, HIPAA sets the standards for how to manage uses and disclosures of patient information, known as Protected Health Information (PHI). But when it comes to information related to the treatment of substance use disorders, regulations of the Substance Abuse and Mental Health Services Administration (SAMHSA) under 42 CFR Part 2 prevail, including rigorous controls on the release and re-release of patient information.
  • 88 Request Info

    HIPAA Boot Camp - Back to the Basics

    Overview: This lesson is going to get back to the basics using multiple real-life scenarios and "what if's". My goal is to make this very confusing and not well explained law easy to understand for the typical staff member.
  • 89 Request Info

    Method Development and Validation for Assays Supporting Testing of Biologics:2-Day In-Person Seminar

    Learning Objectives: Understanding the different requirements for small versus large molecules Mapping appropriate timelines with decision points Designing, developing, optimizing, and validating key methods Potency methods, other release and stability methods Preclinical and clinical methods Use of DOE and statistical analysis Handling of critical materials Process monitoring concepts Assessment of orthogonal methods Assessing readiness for validation Defining the validation protocol with real-time capture of data analysis Maintaining quality through documentation Who will Benefit: Below titles working in biopharmaceuticals, pharmaceuticals, natural products/botanicals will be benefited by attending this seminar: Validation Scientists QA/QC Regulatory Affairs Laboratory Managers Assay Development Specialists Statistician CMC Titles Bio Assay
  • 90 Request Info

    Risk Management in Medical Devices Industry:2-Day In-Person Seminar

    Risk management is a mandatory and necessary process during the entire device life. Not only will it help to design and maintain devices efficiently, but it also ensures that the device will be as safe as possible and prevents harms to patients, users, and the environment. Like any process that tries to produce repeatable and consistent results, the risk management process must be clearly understood, including the strengths but also the limitations. By attending this seminar you will learn the main elements of ISO 14971, ISO 13485, IEC62304, IEC62366-1/-2, risk management life cycle steps and benefits, and FDA software reviewers' guidance.
  • 91 Request Info

    FDA Audit, Quality Assurance Practices, Responsibilities and Expectations:2 days in-person Seminar

    It is no surprise to anyone who reviews regulatory citations to notice the number of deficiencies cited that are associated with quality systems. Today, the basis for all FDA audits both within the US and internationally is based on the quality systems approach and the six systems that comprise it. Whether the audit is a full or partial audit, the quality system within a company will always be inspected and this seminar will help review what are the expectations and the common areas to be familiar with. As a basis for regulatory audits, the quality system, its procedures and their implementation are reviewed to help verify the level of effectiveness in assuring consistent control and quality of materials, components and final product.
  • 92 Request Info

    Identify and Manage Data Integrity Issues, CSV and 21 CFR Part 11:2-Day In-Person Seminar

    The FDA and other Health Authorities worldwide have focused their attention on data integrity, considering data integrity to be a significant risk to public safety. This is evident in the number of Warning Letter observations and related Import Alerts issued in the last 5-7 years. Data integrity is not a new topic, however, but is a part of the GMPs. Often, companies attempt to address data integrity issues procedurally and by conducting numerous training programs. These tend to be ineffective as data integrity issues are often rooted in a company's culture and may be very difficult to address.
  • 93 Request Info

    Lifecycle Management of Analytical Methods and Procedures - according to new FDA and USP guidelines

    Results of analytical methods are used as the basis for important decisions during development and manufacturing of pharmaceutical products. All regulatory agencies expect the regulated industry to have procedures in place to ensure suitable levels of reliability, accuracy and precision of such methods. The procedures should cover lifecycle phases from design, development, validation to on-going routine use.
  • 94 Request Info

    Managing Your Complaints and Obstacles in Post-Market Requirements -- Results from Top Medical Device Observations During an Inspection

    Post-Market activities, Complaint Handling, MDRs, and Recalls are expensive, time consuming, and often lead to more serious financial consequences. Over 80% of FDA Inspection target observations for lack of compliance in these areas.
  • 95 Request Info

    Cleanroom, Microbiology and Sterility Assurance Practices for Drug and Device Manufacturers:2-Day In-Person Seminar

    This course will educate you about various key elements of sterility assurance and contamination control such as Cleanroom Regulations, Classification, Sources and types of particles, Design Requirements, Validation/Qualification, Operations, Environmental Monitoring Program requirements, Excursion investigations, DataTrending, Microbiological processes/methodology, Cleanroom cleaning/disinfection.
  • 96 Request Info

    Implementing UDI (Unique Device Identification) - Plan Now for Success:One Day In-Person Seminar

    The one-day workshop provides the information you need to implement UDI. An effective implementation gives your customers the information they need. It will also help you avoid an FDA 483 and a Warning Letter. The workshop gives you hands on experience to understand UDI and your device. You bring a laptop computer and some information about your device. During the seminar you receive toolkits to determine the compliance dates, packaging configurations, and the attributes you will load to GUDID
  • 97 Request Info

    Biostatistics for the Non-Statistician: 2-Day In-Person Seminar

    Who will Benefit: Persons working in the medical or health sciences, pharmaceutical and or nutriceutical industries, clinical trials, clinical research, and clinical research organizations, physicians, medical students, graduate students in the biological sciences, researchers, and medical writers who need to interpret statistical reports. Physicians Clinical Research Associates Clinical Project Managers/Leaders Sponsors Regulatory Professionals who use statistical concepts/terminology in reporting Medical Writers who need to interpret statistical reports Clinical research organizations, hospitals, researchers in health and biotech fields.
  • 98 Request Info

    Clinical Data Management (FDA E6 GCP Guidelines)

    Learning Objectives: Regulatory guidelines for Clinical Data Management Best practices for data collection CDISC/CDASH/STDM standards Responsibilities of personnel Case report form criteria Maintaining confidentiality of data Data storage and transferability Data preparation and quality assurance for accuracy Data monitoring plan criteria Data systems validation Adverse event reporting and coding criteria What to expect on a monitoring visit Troubleshooting and resolution of deviations from plan Who will Benefit: Study Investigators Data managers Data processors Statisticians Site Personnel Clinical Research Associates Clinical Project Managers/Leaders Study Sponsors Professionals in pharmaceutical, medical device, clinical and biotechnology research who oversee or work with data collection and management Staff in the above fields who work with data collection/management and require training in CDM. Compliance auditors and regulatory professionals who require a knowledge of CDM in asse
  • 99 Request Info

    REACH and RoHS Compliance: Protecting Revenues with Advanced Compliance: 2-Day In-Person Seminar

    Who will Benefit: This seminar will provide valuable assistance to all personnel in: Automotive, Electronics, Medical devices, Chemical, Toys, Industrial machinery Manufacturing Professionals Anyone new to RoHS and or REACH and need to understand the regulations. Anyone responsible for RoHS and REACH compliance. Quality Managers, Environmental Managers, Purchasers, Buyers.
  • 100 Request Info

    Audit Trail Generation and Review

    Overview: This webinar will demystify audit trails and describe the benefits of audit trail for your company. Attendees will the tools required to generate compliant audit trails on a domestic and international basis and will answer the questions on how to handle systems without automated audit trails, in a compliant manner. Why should you Attend: Attendees will learn how to review audit trails, using a risk based approach to cull through the thousands of audit trail records that can be generated on a daily basis.