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Courses

  • 1 Request Info

    The Requirements and Responsibilities of a HIPAA Security/Privacy Officer

    Discussions, presentation, and webinars regarding HIPAA regulations are usually addressed from the perspective of what the regulations entail, the necessity of compliance with the regulations, and the consequences of willful neglect or non-compliance. A great deal of attention is given to the details of new requirements in the regulations when they are published. It is appropriate to address these topics in detail, because they usually require clarification. This presentation addresses HIPAA regulations from a different perspective – from a personal perspective – from the perspective of the person in charge of moving an organization or facility out of “willful neglect” and toward full compliance with HIPAA. The by-product of this presentation will be both an understanding of, and a detailed job description for, a position mandated in the regulations – the HIPAA Security/Privacy Officer.
  • 2 Request Info

    FDA and EMA Global labeling challenges faced in day-to-day operations

    Pharmaceutical companies must manage the process of designing and creating product labels that meet regulatory requirements. This includes product-labeling documents such as Packet Inserts (PIs), Summaries of Product Characteristics (SmPCs) and Core Data Sheets (CDSs). The large number of product strengths, dosage forms and product presentations results in a large number of labeling records that must be maintained and kept synchronized. The FDA and EMA are implementing a set of rules for the electronic submission of labeling content. The FDA labelling regulation requires companies to submit XML labeling content in Structured Product Labeling (SPL) format. The EMA labelling regulation requires companies to submit product information documents in QRD-compliant format.
  • 3 Request Info

    Hazard Analysis following ISO 14971

    The US FDA expects that as part of a product development Design Control Program risk management will be conducted. FDA recommends using ISO 14971 as a guide and has accepted it as a recognized standard. One of the techniques described in ISO 14971 is Hazard Analysis. This is the most powerful of the risk management techniques because it considers risks in normal operation as well as fault conditions. FMEA and FTA consider only fault conditions and are more suited as reliability tools than as product safety tools. In this ISO 14971 risk management training we will explain in detail the process of conducting a hazard analysis. The confusing terms “hazard”, hazardous situation”, “harm”, “causative event”, “ALARP”, “risk index”, “residual risk” will be explained. We will go step by step through a template for hazard analysis so that the process is clear.
  • 4 Request Info

    Telemedicine and being Compliant

    Nearly nine out of 10 family physicians say they would use telehealth to assist in treating their patients if they were compensated for it, according to a survey conducted by the Robert Graham Center for Anthem, Inc. and the American Academy of Family Physicians. Telemedicine is a $27 dollar billion industry set to grow to more than $34 billion dollars by 2020. By next year millions of new members will have access to covered telemedicine services by commercial payers. This growing line of business creates opportunities that require coders to be ready to code these services confidently, navigate the associated rules and reimbursement issues, and understand the emerging procedures associated with telemedicine. This one hour conference provides the listener with these coding insights and more!
  • 5 Request Info

    Qualification of Clean Compressed Air Systems for cGMP Manufacturing

    In the pharmaceutical industry, compressed air is used for a number of production and packaging applications, including blowing off and drying bottles prior to filling, conveying pills, providing air for pneumatically controlled valves and cylinders, as well as breathing air systems. Each of these applications requires a different level of air quality and a different combination of air treatment to meet the needed quality. Because the uses of compressed air within the industry vary so greatly, there is no set standard in place that every process must adhere to. While the FDA may not have issued a directive for compressed air quality in the pharmaceutical industry, there is still a resource available to help select appropriate air treatment components for a compressed air system. A typical pharmaceutical plant might have a compressed air specification of ISO Quality Class 1.2.1—Class 1 for Solids and Dust, Class 2 for Humidity and Liquid Water, and Class 1 for Oil.
  • 6 Request Info

    Medical Terminology - Online Course

    Accredited self-paced online Medical Terminology class. This class combines an interactive study experience with the convenience of the Internet. Students can enroll at any time and complete the course at their pace. Begin learning Medical Terminology today! College credit is available for an additional fee.
  • 7 Request Info

    Anatomy & Physiology - Online Course

    Accredited self-paced online Anatomy & Physiology course. This course combines an interactive study experience with the convenience of the Internet. Students can enroll at any time and complete the course at their pace. Start learning A & P today! College credit available for an additional fee.
  • 8 Request Info

    Medical Coding - Online Course

    Accredited self-paced online Medical Coding training. This course covers ICD-10, HCPCS, and CPT and is approved by the AAPC. Students can enroll at any time and complete the course at their pace. Begin learning Medical Coding today!
  • 9 Request Info

    Team Building Excellence for Managers and Supervisors

    Dr. Rick Goodman is a professional speaker, motivator, author and training consultant helping organizations Develop Great Leaders - Through Excellence in Communication, Team Building, Change Management, and Customer Excellence. Dr. Rick = RESULTS
  • 10 Request Info

    Conflict Management

    Dr. Rick Goodman is a professional speaker, motivator, author and training consultant helping organizations Develop Great Leaders - Through Excellence in Communication, Team Building, Change Management, and Customer Excellence. Dr. Rick = RESULTS
  • 11 Request Info

    How to Be a More Effective Team Leader

    Dr. Rick Goodman is a professional speaker, motivator, author and training consultant helping organizations Develop Great Leaders - Through Excellence in Communication, Team Building, Change Management, and Customer Excellence. Dr. Rick = RESULTS
  • 12 Request Info

    Clinical Trial Recruitment Methods and Metrics

    Recruitment of research participants into clinical trials is critical. As the trials are designed for human subjects or use of a person's private identifiable information, a human subject's research study cannot occur with people. Yet, enrollment issues continue to be one of the reasons why trials are held open longer than anticipated and why modifications to the study are needed to increase enrollment. This increases administrative burden and study costs. To help combat this, studies have been done using a variety of metrics to help determine which recruitment strategies are the most effective in given situations.
  • 13 Request Info

    Agile Meets Software Standards, and We all Win

    Overview: Understanding TIR 45 can be the roadmap for improving development and benefiting everyone, companies, development teams, caregivers, patients, and regulators. Why should you Attend: Perhaps you're a development manager, hoping to improve both productivity and quality. Or you are a quality assurance manager, facing a demand from management and development to permit a move to Agile.
  • 14 Request Info

    How to Conduct a Human Factors

    Overview: This webinar will explain the procedure described in ISO62366 and the 2016 FDA Guidance for a compliant human factors/usability validation. HF/U validation is very different from device validation. For example, success criteria is qualitative rather than quantitative as is in device validation. Claiming success because eg. 95% of test participants did not commit a user error is not valid. Nor is 100% positive test results sufficient.
  • 15 Request Info

    Troubleshooting of Pharmaceutical Water Systems | Washington Seminar

    This course is designed to provide a microbiology-focused education about all aspects of water systems and how biofilm manages to thrive there. Prior microbiological education or training, though a plus, is not a requirement because engineers and other non-biologists also need this training if they are involved with any aspect of water systems. The instructor will provide the necessary background needed to understand this very important subject matter.
  • 16 Request Info

    What is Human Factors and why is it Important?

    Overview This webinar is tailored to provide an overview of human factors and the benefits of applying human factors within the design process and ongoing system operations.
  • 17 Request Info

    Handling OOS Test Results and Completing Robust Investigations

    Overview This webinar will review the regulatory requirements for investigating an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed. A detailed flow chart will be used to help the attendees clearly understand the steps and the order in which they are to be performed. The structure of an Investigation report which properly documents the investigation will be discussed.
  • 18 Request Info

    Estimating Reliability Performance with Accelerated Life Tests

    This webinar on Estimating Reliability Performance of products will show how you can use Accelerated Life Testing methods (ALT) to reduce costs, minimize risks and ensure adequate product performance prior to launch.
  • 19 Request Info

    Failure Modes and Effects Analysis - An effective Risk Management Tool

    Overview This Medical device training will acquaint one with the various terms used in risk management and the importance of ISO 14971 & ISO 13485 in the managements of risks during the life cycle of medical devices starting with design and manufacture.
  • 20 Request Info

    HIPAA Compliance for Healthtech and Software Start-ups

    Overview: Healthcare is an industry ripe for innovation and disruption. Many entrepreneurs see opportunity but hold back because they are unsure how to navigate the complexities of HIPAA and protecting patient data.