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  • 1 Request Info

    Webinar On Medical Records: Responding to Subpoenas and Investigations

    Learn how to respond to subpoenas and investigations while complying with HIPAA requirements, state law regulations and patients' privacy rights.Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://onlinecompliancepanel.com/webinar/MEDICAL-RECORDS-506966/APRIL-2017-ES-TRAININGREGISTRY
  • 2 Request Info

    Webinar On Medical Device Recalls: a Preventive Strategy

    The secret to preventing medical device recalls is to implement and follow basic practices for specifications and design control, design for process reliability, production validation and design validation using accelerated life tests. This webinar is about controlling safety risk from specification writing to device retirement - control throughout the product's life cycle.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://onlinecompliancepanel.com/webinar/MEDICAL-DEVICE-RECALLS-509325/APRIL-2017-ES-TRAININGREGISTRY
  • 3 Request Info

    Webinar On Auditing for EMTALA Compliance

    This webinar is designed to walk attendees through a process for auditing your organization's compliance with The Emergency Medical Treatment And Labor Act (EMTALA). More specifically, it will provide an overview of EMTALA, discuss key compliance challenges facing organizations that must comply, and discuss a step-by-step approach for routine and periodic auditing.Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://onlinecompliancepanel.com/webinar/EMTALA-COMPLIANCE-503159/APRIL-2017-ES-TRAININGREGISTRY
  • 4 Request Info

    Applying U.S. FDA Laws and Regulations to Each Phase of Total Product Life Cycle (TPLC)

    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
  • 5 Request Info

    Roadmap to Advanced Human Resources and Employment Law 2017

    Are You Prepared for the New Presidential Administration? Is your company at risk for non-compliance? Is your company a lawsuit waiting to happen? 2017 comes in with a lot of uncertainties. With a new administration in the white house, employers can expect drastic change, which may affect and impact your organization. Additionally, employment lawsuits are on the rise. Last year, Equal Employment Opportunity Commission (EEOC) enforcement collected $372.1 million in monetary damages, the highest recovery in agency history. Also, for the last three years, the EEOC reported a record high number of claims filed by employees. When employers are not properly prepared for workplace issues, companies could face discrimination suits, litigation, settlements, lawyer fees, unplanned expenses, employee turnover, morale issues, and possible negative community image. This Advanced Human Resources and Employment Law Seminar will assist companies in being prepared for the new administration,
  • 6 Request Info

    Incorporating Risk Management into Your HR Policy 2017

    HR audits are designed to help your organization focus its attention on its human resource management practices, policies, procedures, processes, and outcomes by providing you with a structured and systematic series of questions about key compliance, risk management, internal auditing, and human resource management issues. As a process, HR audits are designed to help your organization identify potential and actual problem areas, help assess the effectiveness of current HR management activities, help assess weaknesses in HR internal control processes, and help assess human capital strategic and compliance related risks. HR audits should additionally provide suggestions for corrective action.
  • 7 Request Info

    FDA's GMP Expectations for Phase I and First-in-Man Clinical Trials 2017

    Early clinical trials are conducted to establish initial safety of a drug. The studies are generally in small number of healthy subjects and use lower doses of the drug product. Therefore, only small amounts of investigational material are required. In order to not undertake substantial costs and to reduce regulatory burden during these early stages, the FDA has established guidelines to allow early stage investigational products to be manufactured under less stringent GMPs. Why should you attend: To gain an understanding of the requirements for advancing drugs from research into early clinical development and the minimum FDA requirements for phase I GMPs. To learn practical applications for implementing phase I manufacturing strategies to meet FDA requirements.
  • 8 Request Info

    Human Factors and Predicate Combination Products 2017

    The FDA has placed significant emphasis on the role of Human Factors in the approval of devices used for medical purposes. There are several current guidance documents and new proposed Draft Guidance documents. This seminar will compare these Guidance documents. Additionally, strategic recommendations will be presented on how to implement these requirements into the medical device design, development and approval processes. Finally, Human Factors methods and best practices will be covered that the FDA is requiring. Why should you attend: Are you familiar with the role of Human Factors with respect to combination products and the FDA requirements? Are you current on the FDA's current perspectives on Human Factors? Human Factors has become increasingly important to the FDAs approval of medical devices. It is a part of the design and development of the device and the collateral information, e.g., labeling, IFUs, and training. Incorporating Human Factors into the device development
  • 9 Request Info

    Developing Technical Training in the Life Sciences 2017

    Developing Technical Training in the Life Sciences is a 2-day seminar that addresses the unique challenges of developing and managing training in Life Sciences companies. The Life Sciences pose unique challenges to training developers. The first day of this seminar will concentrate on providing foundational knowledge concerning training and development within the Life Sciences. Four 90 minute sessions will be presented on this first day that will guide the participant from a discussion of the role and function of the technical training function to the actual creation of the training organization. Important to this first day, are discussions of performance-based training, the fundamentals of training (jobs, duties, tasks, and steps to include performance objectives) and how human performance and training are inextricably linked. Knowing about human performance and how to apply human performance principles are crucial to designing, developing, and managing an effective technical
  • 10 Request Info

    Background Checks, Criminal Records and Safe Hiring 2017 Effective and Compliant Program 2017

    Employee problems are caused by problem employees, and this session will help HR professionals legally avoid bad hires in the first place. Just one bad hire can result in a legal and financial nightmare. Without taking appropriate steps, there is a near statistical certainty that an employer will hire someone with an unsuitable criminal record, or a falsified background, that can result in workplace violence, lawsuits for negligent hiring and time wasted recruiting and hiring the wrong person. On the other side of the screening fence, are the rising tides of lawsuits against employers alleging screening methods violate the law or are at odds with changes in civil rights legislation and the new EEOC Guidance on the use of criminal records. The screening landscape is more complex than ever.
  • 11 Request Info

    Medical Device Single Audit Program for Compliance Success (MDSAP) 2017

    Reviewing the most significant changes affecting medical device standards and guidance documents Understanding the MDSAP (goals and strategy) Analyzing the MDSAP main differences with standard auditing Understanding grading of MDSAP non-conformances Assessing MDSAP Audit structure and reporting to regulators More than six Notified Bodies are in the Pilot Program, Office audits and witnessed audits are required (conducted by regulators) And Much More...
  • 12 Request Info

    Applied Statistics, with Emphasis on Risk Management 2017

    The 2-day seminar explains how to apply statistics to manage risk in R&D, QA/QC, and Manufacturing, with examples derived mainly from the medical device design/manufacturing industry. The flow of topics over the 2 days is as follows: ISO standards and FDA/MDD regulations regarding the use of statistics. Basic vocabulary and concepts. Statistical Process Control Statistical methods for Design Verification Statistical methods for Product/Process Qualification Metrology: the statistical analysis of measurement uncertainty, and how it is used to establish QC specifications How to craft "statistically valid conclusion statements" (e.g., for reports) Summary, from a risk management perspective
  • 13 Request Info

    Modern HIPAA Compliance - Managing Privacy, Security, and Breach Notification in a World of New Technologies, New Threats, and New Rules 2017

    Day one sets the stage with an overview of the HIPAA regulations including HIPAA Breach Notification and the process that must be used to determine whether or not a breach is reportable, and then continues with presentation of the specifics of the Privacy Rule, recent changes to the rules, and the basics of the Security Rule. Rules about Patient Rights and the limitations on uses and disclosures by covered entities will be explained, including recent guidance on access of PHI by individuals and sharing information with family and friends of a patient, and the latest rule changes for substance abuse information under 42 CFR Part 2. Discussion will include the impacts of the 21st Century Cures Act as well as the repeal of the Affordable Care Act, and potential impacts of privacy concerns combined with immigration crackdowns on the accuracy and completeness of records on individuals who may fear deportation.
  • 14 Request Info

    HIPAA Compliance Training 2017

    This two day seminar takes the participants through HIPAA compliance from start to compliance. 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. The materials take the participant through the factors of HIPAA compliance and how to perform a HIPAA Risk Assessment. This encompasses taking the participants through how to do a HIPAA Privacy Risk Assessment, how to do a HIPAA Security
  • 15 Request Info

    Audit Like the FDA Audit Like the FDA 2017

    This 2 day seminar will explore how to create and implement an efficient and effective internal audit program. Internal Audit is a required part of an effective quality system. More importantly, it is an incredibly powerful tool to identify areas of non-compliance. A well-designed audit program can be an effective tool in understanding, communicating, and reducing quality and compliance risk. However, estimates indicate that up to 75% of companies conduct audits only because they are required to by regulation. Businesses often see internal audit as a non-value added activity leading to meaningless findings, bureaucracy, and cumbersome processes. And despite having an internal audit program, management is often surprised when they receive a 483, Warning Letter, or even a Consent Decree. A well planned audit program can reduce these risks.
  • 16 Request Info

    Webinar On Falsifying Data in Clinical Trials: What to Report?

    Falsifying data in clinical trials is also considered data fraud. When data fraud occurs there are most likely other unreported or undetected misconduct that occurred within a clinical trial. This leads to poor, unreplicable results. When results cannot be replicated, questions arise about why a trial was conducted and what types of risks or harms were the participants exposed to.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://onlinecompliancepanel.com/webinar/FALSIFYING-DATA-CLINICAL-TRIALS-502132/MARCH-2017-ES-TRAININGREGISTRY
  • 17 Request Info

    Webinar On Classifying Medical Devices - US and EU

    This webinar will detail the medical device classification process for the United States through the FDA and will overview the very complex process for medical device classification within the EU. Specifically, this webinar will provide detailed background into the process and will make clear some of the very complex terms and sub-processes associated with medical device classification. We will actually work through the classification process step-by-step for the US and will overview how the process is accomplished for the EU.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://onlinecompliancepanel.com/webinar/CLASSIFYING-MEDICAL-DEVICES-505796/MARCH-2017-ES-TRAININGREGISTRY
  • 18 Request Info

    Webinar On How to Apply for a Breakthrough Therapy Designation and Win It

    This webinar, presented by a leading regulatory affairs expert with successful BTDs, discusses FDA expectations from BTD requests, the best practices to write a BTD request, and pros and cons of applying for a BTD. The session will highlight key regulatory requirements, dos and don'ts, common areas of concern, and trouble-shooting BTD requests using case studies and examples from the presenter's vast experience helping companies big and small in successfully applying for a BTD.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://onlinecompliancepanel.com/webinar/BREAKTHROUGH-THERAPY-DESIGNATION-504525/MARCH-2017-ES-TRAININGREGISTRY
  • 19 Request Info

    Webinar On Medical Device Premarket and Post market Cyber security following the new FDA Guidances

    Medical devices, like other computer systems, can be vulnerable to security breaches, potentially impacting the safety and effectiveness of the device. This vulnerability increases as medical devices are increasingly connected to the Internet, hospital networks and to other medical devices. This webinar will describe a program that will minimize risk to the user from cyber attacks.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://onlinecompliancepanel.com/webinar/MEDICAL-DEVICE-PREMARKET-POST-MARKET-CYBER-SECURITY-509863/MARCH-2017-ES-TRAININGREGISTRY
  • 20 Request Info

    Webinar On MACRA Performance and the Role of Chronic Care Management Services: Meeting the MACRA Requirements while Boosting Revenue in your Practice

    This course will review the components of the Medicare Access and CHIP Reauthorization Act (MACRA) that overlap with the Medicare Chronic Care Management (CCM) initiative. The two program overlap in several ways and are complimentary. Engaging in both programs will allow practices to improve MIPS scores and achieve Advanced APM objectives while generating additional revenue from the CCM program.Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://onlinecompliancepanel.com/webinar/MACRA-PERFORMANCE-REQUIREMENTS-501936/MARCH-2017-ES-TRAININGREGISTRY