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Courses

  • 61 Request Info

    When Conducting cGMP Regulatory Inspections 2019

    Overview: It has often been stated that "FDA inspects for compliance; European inspectors inspect for adequate science". Yet GMPs have been enshrined into law for many countries and a drug/biologic/medical device manufacturer should have a reasonable expectation of all inspections being the same.
  • 62 Request Info

    6-Hour Virtual Seminar on Designing Stark Compliant Physician Compensation Models

    This session is designed for health care executives, physicians and other health care providers who participate in and receive remuneration from Medicare, Medicaid, and other federal health care programs such as TriCare. Several recent cases bring home the realization that Stark II (the physician anti-referral law) is alive, still with us and as viable as ever, and it can be used as the basis of a False Claims Act action. As a health care executive, physician or other health care provider, you should be very concerned about the potential for Stark II, as well as the Anti-Kickback Statute, being used as the basis for an action brought under the Federal False Claims Act. In this webinar, you will learn about the elements of the Stark II law, along with the various exceptions and safe harbors that you can rely on for protection against enforcement under this law.
  • 63 Request Info

    6-Hour Virtual Seminar on Controlling Human Error in the Manufacturing Floor

    Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrences. To work with these challenges, it is essential to understand human behavior and the psychology of error as well as understand exactly where the weaknesses of the system are so that they can be improved and/or fixed.
  • 64 Request Info

    6-Hour Virtual Seminar on Batch Record Review and Product Release

    Most Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records. Additionally, there must be written procedures for a batch record review process that demonstrate compliance. A strong batch record review system is essential in order to properly document all critical processing parameters that go along with the production and manufacture of pharmaceuticals, biologics, medical devices, etc.
  • 65 Request Info

    Transforming HR through Six Sigma: Adopting a New Way of Thinking About Human Resources

    What is Six Sigma? Six Sigma is a powerfully dynamic approach to process improvement in order to do things better, faster, and at a lower cost. It has been applied to every facet of business, ranging from production to human resources, to order entry and technical support. Six Sigma began in the mid-1980s at Motorola in response to the needs of a sale force faced with increasing customer dissatisfaction and competitive pressures. To address these issues, Motorola developed a set of formulas and tools to identify and measure performance based on your customer's inputs in order to increase efficiency.
  • 66 Request Info

    Adaptive Communications

    Overview Do you have to communicate with people who make you want to pull your hair out (for those of us who still have hair)? You communicate very clearly and they just don't "get" it - its like they are not even hearing you. It can be so frustrating trying to get your message across. And then there are the people that talk too much without saying anything -they seem to talk just to hear themselves talk -it's so annoying. Or those that don't communicate at all -are you supposed to read their minds -its exhausting trying to get anything substantive out of them.
  • 67 Request Info

    How to Deal With Clashing Co-Workers?

    Overview Employee conflict costs organizations money, morale, and productivity. A rise in absenteeism and turnover is a likely sign that an organization is suffering from unresolved conflict. In this webinar, you will learn how to handle conflicts caused by the tasks of the job and relationships with coworkers. You will learn how to evaluate the seriousness of the conflict and how to appropriately intervene. In addition, the role of emotional intelligence, confronting employees in conflict and dealing with common issues of conflict at all levels of the organization will be considered.
  • 68 Request Info

    Compliance Payroll Style (Update of Rules and Limits for 2019)

    Overview Make sure you are up to date on important payroll compliance issues. The webinar will discuss 2019 limits, the effects of the current legal case against the FLSA overtime changes; a look at unemployment issues for 2019. We'll also look at FUTA Credit Reduction states for 2018 returns. Changes to state minimum wages, tip credit and new players in the Paid Family Leave area will be addressed. A look at any effects of the government shutdown will also be included.
  • 69 Request Info

    AQL Sampling Plans for Risk Management in Incoming QC

    Overview: The pros and cons of the 2 most widely used sampling plans (ANSI Z1.4, and Squeglia's C=0) are examined in detail, focusing especially on the weaknesses of such plans in regards to meeting regulatory requirements. Real-world examples are provided for how using such sampling plans leads to production of non-conforming product. The advantages of "confidence/reliability" calculations are explained. Such calculations are demonstrated for Attribute data (pass/fail, yes/no data) as well as for variables data (i.e., measurements). If variables data is "Normally distributed" the calculations are extremely simple. The webinar explains how to handle "non-Normal" data, and provides the methods, formulas, and tools to handle non-normality.
  • 70 Request Info

    Annual ACH Rules Compliance Audit a Step-by-Step Guide

    Overview: The NACHA Operating Rules and Guidelines require that all participating depository financial institutions, third-party senders and third-party service providers that provide ACH services conduct an annual ACH audit to be performed by December 31 of each year (ACH Rules, Article 1). With the requirement that each participant conducts an annual ACH audit, this helps to ensure that electronic payments work safely and efficiently for all users. Why should you Attend: Due to a recently approved amendment to the NACHA Operating Rules, Appendix 8 has been removed from the Rules (Appendix 8 was the "guide" or checklist while completing the annual ACH Audit).
  • 71 Request Info

    Third-Party Sender Registration - Are you in Compliance?

    Overview: The ODFI is responsible for the registration process for any Third-Party Senders and nested TPS; registration is also necessary even if there is no TPS relationship. Why should you Attend: The registration process will promote consistent customer due diligence among all ODFIs, and serve as a tool to support NACHA's continuing efforts to maintain ACH Network quality.
  • 72 Request Info

    Your Most Burning Questions About Fishbone Diagramming 2019

    Overview: Fishbone Diagramming is an analytical approach used to identify and solve problems. Analysis is presented in the Seven Basic Tools of Quality in addition to advanced methods used to increase organizations effectiveness, efficiency and reliability. Specific areas presented: Look for Evidence The Post-it Exercise Pareto Chart Fish Bone Diagramming Process Reliability Modeling Critical Path Analysis Value Stream Mapping Failure Mode Effects Analysis
  • 73 Request Info

    Seminar on Phase I GMPs

    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. More: https://www.globalcompliancepanel.com/seminar/seminar-on-phase-I-GMPs-901939SEMINAR/?SEO
  • 74 Request Info

    Seminar on Applying ISO14971 and IEC62304 - A guide to practical Risk Management

    Gaps, incorrect or incomplete implementation of safety functionality 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 devices in a regulatory compliant environment. This course will additionally address the software risk management and the resulting interfaces to device level risk management. To comprehensively summarize all risk related activities and to demonstrate the safe properties More: https://www.globalcompliancepanel.com/seminar/applying-ISO14971-and-IEC62304-901942SEMINAR/?SEO
  • 75 Request Info

    Seminar on Biostatistics for the Non-Statistician

    Why should you attend: 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? More Information Click Here: https://www.globalcompliancepanel.com/seminar/biostatistics-for-the-non-statistician-901936SEMINAR/?SEO
  • 76 Request Info

    Webinar on Visualizing Excel Data with Smart Art Presentations and Charts

    Learn the tips and tricks of visualizing Excel Data with Smart Art presentations and charts. Register today for the webinar. Price:$150.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link - https://www.onlinecompliancepanel.com/webinar/Visualizing-Excel-Data-with-Smart-Art-Presentations-and-Charts-505000/JANUARY-2019-ES-TRAININGREGISTRY
  • 77 Request Info

    Theory and Practice of Near-Infrared Spectroscopy

    Overview: NIR is more complex than typical spectroscopic methods. This webinar will compare and contrast NIRS with “commonly used” spectrometers, now in use and more familiar to analysts. Why should you Attend: These can be hand-held, lab-based, or installed in process lines This webinar will explain the manner in which NIR works, the equipment available, and the applications where it may best be used. After this webinar, you will be able to evaluate which type of NIR would be best for your application
  • 78 Request Info

    What is Human Factors and why is it Important?

    Overview: This webinar provides a fundamental level appreciation of human factors and how it has been implemented within the engineering discipline to improve design and operation to support system goals. Why should you Attend: Understand the definition and scope of human factors Recognize the benefits of user centred design Identify opportunities where HF may improve current processes and designs Discuss the regulatory environment in several jurisdictions
  • 79 Request Info

    3-Hour Virtual Seminar on FDA's Scrutiny of Social Media Promotion

    Overview: FDA steadily expands the scope and restrictions for promotion of products under its jurisdiction. Whatever and where ever to want to talk about your product, just assume your talking to FDA. Trolling for off-label information in social media, scrutiny of educational material under "safe harbor" and apparent conflicts of interest at a public event create a sink hole for firms even though it may seem innocent in your eyes.
  • 80 Request Info

    Things To Do Immediately About Master Validation Plan 2019

    FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based company-wide V&V planning. Starting with a Master Validation Plan, evaluating its elements against ISO 14971 hazard analysis / risk management, allows development of meaningful product validations. The roles of different V&V protocols.