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  • 1 Request Info

    HIPAA and The IT Manager Webinar

    Overview: 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.
  • 2 Request Info

    HIPAA and Human Resources Webinar

    This lesson will be addressing what human resources managers need to know regarding health records of their employees. We will go through "do's and don'ts"and cover many frequently asked questions I have received through my 17-year career in HIPAA compliance. Human resources managers need to get their HIPAA house in order as this law is now fully enforced across the board 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 2017 and beyond. 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 individuals 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 within the HR department as a whole
  • 3 Request Info

    Webinar on How to Manage the HIPAA Business Associate Process

    Overview: The webinar will cover how to find out if business associates have the necessary technical, physical and administrative safeguards in place to protect shared protected health information. The webinar will address when a vendor becomes a business associate and how that relationship may change the dynamics. Understanding the Business Associate Agreement (BAA) process and making sure all ten government mandated requirements are in place will be covered. Find out about the use of Vendor Security Questionnaires and how to implement. The webinar will cover breaches caused by business associates and how to handle such an occurrence. If your healthcare organization needs to understand what your responsibilities are in managing business associates, please join us for this informative and interactive course
  • 4 Request Info

    2017 Webinar on Structuring and Auditing Non-Physician Practitioner Arrangements

    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: As health care organizations and physicians develop NPP arrangements, they must manage their compliance and enterprise risk by ensuring the their arrangements are defensible under the Stark Law. 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.
  • 5 Request Info

    Webinar on HIPAA Security Rule - Explained

    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 HIPAA Security Rule and any other applicable updates for 2017. Areas also covered will be texting, email, encryption, medical messaging, voice data and risk factors as they relate to IT. I will also go into details regarding the top areas of non-compliance relating to the Security Rule and common sense ways (and resources) to get this fixed! he 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 regarding the do’s and don'ts with HIPAA
  • 6 Request Info

    Lineament analysis and appropriate sampling and Quality Assurance 2017- Before 30 April 50% Discount for its All Seminars

    Upon completing this course, participants should: Understand the limitations of the current exploration process Learn to use lineament and satellite interpretation as a way to define where to concentrate their exploration efforts How to implement QA&QC; procedures to guarantee the quality of the collected data Why you should attend: We will introduce you to an effective and affordable methodology that identifies prospective targets which are related to, or controlled by tectonic structures. Even over new areas with limited or nonexistent geological information, we are able to help you concentrate your exploration efforts to keep your budget in the black. Read More : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901014SEMINAR?trainingregistry_SEO
  • 7 Request Info

    Overview of Device Regulation - FDA 2017- Before 30 April 50% Discount for its All Seminars

    This course provides a basic description of an FDA regulatory strategy for medical devices and explains the relationships between regulatory strategy and product development. It offers guidelines for developing successful strategies for medical devices, including definitions and classifications, elements of regulatory strategy, sources of regulatory intelligence, selection of development and product clearance/approval pathways. Read More : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900902SEMINAR?trainingregistry_SEO
  • 8 Request Info

    Risk Management in Medical Devices Industry 2017- Before 30 April 50% Discount for its All Seminars

    Gaps, incorrect or incomplete implementation of software 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 device software in a regulatory compliant environment. Software risk management has to be embedded into the bigger scope of overall risk management. Therefore this course will additionally address the system level risk management and the resulting interfaces to software. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900890SEMINAR?trainingregistry_SEO
  • 9 Request Info

    Good Clinical Practices (GCP) - Understanding and Implementing the Current Global Requirements 2017- Before 30 April 50% Discount for its All Seminars

    Defining the basic requirements of Good Clinical Practices Clinical Study Protocol Elements and Device Accountability Role of Institutional Review Board (IRB) and Informed Consent Principles of Ethics and Quality Control Determining the appropriate duties and oversight required of the sponsor, monitor, and investigators to ensure a high level of quality in a clinical trial Ensuring that quality practices are designed and implemented to guarantee compliant clinical trials Learning how to effectively manage a Sponsor, as well as, an FDA GCP inspection Developing mechanisms to uncover and preclude fraud and misconduct in clinical trials And Much More... Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900978SEMINAR?trainingregistry_SEO
  • 10 Request Info

    Good Clinical Practices (GCP) - Understanding and Implementing the Current Global Requirements 2017- Before 30 April 50% Discount for its All Seminars

    Defining the basic requirements of Good Clinical Practices Clinical Study Protocol Elements and Device Accountability Role of Institutional Review Board (IRB) and Informed Consent Principles of Ethics and Quality Control Determining the appropriate duties and oversight required of the sponsor, monitor, and investigators to ensure a high level of quality in a clinical trial Ensuring that quality practices are designed and implemented to guarantee compliant clinical trials Learning how to effectively manage a Sponsor, as well as, an FDA GCP inspection Developing mechanisms to uncover and preclude fraud and misconduct in clinical trials And Much More... Read More : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900976SEMINAR?trainingregistry_SEO
  • 11 Request Info

    Laboratory, Medical and Device Performance 2017- Before 30 April 50% Discount for its All Seminars

    This course is designed to introduce to individuals the understanding and interpretation of the statistical concepts one uses when investigating quantitative ICH Guidelines such as analytical methods validation, procedures and acceptance criteria in calibration limits, and process and quality control. One also considers ICH Q8 and Q9. These techniques covers both clinical and laboratory applications. This applies to many areas such as stability testing, outlier analysis and risk management. It is not a course in statistics but introduces the participant to an applied approach to the statistical techniques one uses, how they are reasonably interpreted. One will address the various challenges facing pharmaceutical and biotechnology companies when it comes to quantifying results in a meaningful interpretable manner through tabulations and graphical presentations. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900932SEMINAR?trainingregistry_SEO
  • 12 Request Info

    Quality by Design using Design of Experiments (QbD) 2017- Before 30 April 50% Discount for its All Seminars

    This seminar focuses on how to establish a systematic approach to pharmaceutical development that is defined by Quality-by-Design (QbD) principles using Design of Experiments (DOE). In addition, this course teaches the application of statistics for setting specifications, assessing measurement systems (assays), developing a control plan as part of a risk management strategy, and ensuring process control/capability. All concepts are taught within the product Quality System framework defined by requirements in regulatory guidance documents. Using a QbD approach for pharmaceutical development studies should include a systematic understanding of the process and using this understanding to establish a control strategy as part of a comprehensive quality risk management program. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901008SEMINAR?trainingregistry_SEO
  • 13 Request Info

    HIPAA Compliance for Small Healthcare Providers 2017- Before 30 April 50% Discount for its All Seminars

    Being in compliance with HIPAA involves not only ensuring that you provide the appropriate patient rights and controls on your uses and disclosures of Protected Health Information; but that 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 fundamentals of a HIPAA compliance program. If your small healthcare practice needs to understand how to put a HIPAA compliance program in place or make sure the current program is adequate and can withstand government scrutiny, please join us for this informative and interactive Two-day training course. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901022SEMINAR?trainingregistry_SEO
  • 14 Request Info

    Writing and implementing effective SOP's 2017- Before 30 April 50% Discount for its All Seminars

    An SOP is a meticulous step-by-step description of how to do a task that leave no chance for errors and divergence. Writing a good SOP is not an easy job. It requires a firm understanding of the task to be described, an ability to describe in specific unique to that laboratory. Writing, implementing, maintaining and assessing, revising an SOP are all different and necessary jobs. Many people must continuously be involved in these steps. Even a standardized method, such as an ASTM or IP method, is insufficiently written to pass as a well-written and compliant SOP. The reasons why will be described, as will the steps needed to convert a standard method into an SOP. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900914SEMINAR?trainingregistry_SEO
  • 15 Request Info

    New FDA FSMA Rules 2017- Human and Animal Foods- Before 30 April 50% Discount for its All Seminars

    Transportation and Logistics food transportation food safety rules are currently being finalized by the U.S. Food and Drug Administration (FDA). Under congressional instructions, the Food Safety Modernization Act (FSMA) requires the FDA to establish rules to improve, audit and enforce new food transportation rules. The rules provide a significant focus on foods not completely enclosed by a container, risk reducing adulteration prevention, personnel training and certification, inspection and data collection, maintenance and reporting that provides evidence of compliance. In this two day workshop conference you will learn the legal requirements, how to develop a company plan that meets FDA and your customer requirements. You will review and learn how to establish appropriate Read More : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900994SEMINAR?trainingregistry_SEO
  • 16 Request Info

    Supplier Management in FDA- and ISO-regulated Industry 2017- Before 30 April 50% Discount for its All Seminars

    Supplier qualification and assessment is required in both the QSR regulations and ISO standards. Many companies spend a great deal of time and money in pursuit of compliance. Many companies can spend significantly less time and money, and still be in control of their suppliers and in compliance with the regulations. This class will review the QSR and ISO requirements for supplier evaluation, including defining the types of suppliers that require evaluation. The QSR/ISO requirements for supplier assessment will be defined as well. Read More : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901000SEMINAR?trainingregistry_SEO
  • 17 Request Info

    Applied Statistics for Scientists and Engineers 2017- Before 30 April 50% Discount for its All Seminars

    Throughout 21 CFR and guidance documents for the pharmaceutical, biopharmaceutical, and medical device industries, the application of statistical methods are specified for: setting validation criteria and specifications, performing measurement systems analysis (MSA), conducting stability analysis, using design of experiment (DOE) for process development and validation, developing process control charts, and determining process capability indices. Different statistical methods are required for each of these particular applications. Data and tolerance intervals are common tools used for setting acceptance criteria and specifications. Simple linear regression and analysis-of-covariance (ANCOVA) are used for setting expiries and conducting stability analysis studies. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900788SEMINAR?trainingregistry_SEO
  • 18 Request Info

    HIPAA for the Compliance Officer 2017- Before 30 April 50% Discount for its All Seminars

    I will be going into great detail regarding you practice or business and how it relates to the HIPAA Security/Privacy Rule, Areas covered will be history of HIPAA, privacy vs security, business associates, changes for 2016, audit process, paper based PHI, HIPAA and suing, texting, email, encryption, medical messaging, voice data and much, much, more I will uncover myths versus reality as it relates to this very enigmatic law based on over 600 risk assessments performed as well as years of experience in dealing directly with the Office of Civil Rights HIPAA auditors. I will also speak to real life audits conducted by the Federal government (I've been on both sides of these audits) what your highest risks are for being fined (some of the risk factors may surprise you). Read More : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900962SEMINAR?trainingregistry_SEO
  • 19 Request Info

    Seminar on Applying U.S. FDA Laws and Regulations to Each Phase of Total Product Life Cycle (TPLC)- Before 30 April 50% Discount for its All Seminars

    This workshop style training course is supported by comprehensive knowledge of U.S. FDA laws and regulations and 30 year of extensive experience working within in the U.S. FDA regulated industries. In these 2 days, the following essential topics will be covered: Total Product Life Cycle and Your Medical Device An Overview of U.S. FDA Medical Device Regulation Regulations for Design and Product Development Premarket Notification - 510(k) and Premarket Approval (PMA) Regulations for Production & Process Control Readiness for FDA Facility Inspection Read More : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900772SEMINAR?trainingregistry_SEO
  • 20 Request Info

    Marketing, Advertising and Promotion of Pharmaceuticals and Medical Devices 2017- Before 30 April 50% Discount for its All Seminars

    The changing game for drug and device marketing, however, is governed by antiquated and inadequate rules created for traditional print and broadcast advertising by the Food and Drug Administration ("FDA"). How the FDA will deal with such advanced communication technology that can go "viral" and just as quickly disappear is the question that the industry is eager to have answered. The FDA regulates the promotion of prescription drugs, biologics, medical devices and biotechnology products to ensure that the information is not false or misleading. The FDA has for decades regulated traditional advertising for decades, published various guidance documents for industry and issued many violation letters. Read More : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900970SEMINAR?trainingregistry-SEO