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  • 41 Request Info

    Software Risk Management 2018

    Risk Management is a regulatory and statutory requirement for medical devices. The generic procedure to perform risk management is outlined in ISO14791, however, as soon as software is used challenges arise. How to address these specific software issues and the application of FDA and IEC requirements for development of safety-critical software used in medical devices is the content of this seminar.
  • 42 Request Info

    Assessing and Planning for Risk (Latest 2018)

    The larger, more complex, and longer your project is, the more likely some aspects won't work out as you envisioned. You have the greatest chance for success if you confront the possibility of unexpected changes head-on and if you plan how to minimize the consequences of those changes from the outset.
  • 43 Request Info

    Project Management for Non-Project Managers (2018 Estimating Resource Needs)

    Overview: After developing your schedule, you need to plan your resource allocation. Planning your personnel needs begins with identifying whom you need and how much effort they have to invest. This analysis provides you with a clear description of accountability and responsibility, a way to track costs and work assignments, and an identification of when too many or too few resources are being assigned.
  • 44 Request Info

    CAPA for Medical Devices 2018

    You'll learn how to streamline and monitor your process to ensure compliance and improved performance. If your CAPA process needs a CAPA, this webinar is for you. In this 3-hour webinar, you'll learn how to streamline and monitor your process to ensure compliance and improved performance. If your CAPA process needs a CAPA, this webinar is for you.
  • 45 Request Info

    What are the Tools required for Human Error Reduction

    Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally 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.
  • 46 Request Info

    Design Control is Critical to Product Quality

    This 90-minute webinar will cover the basics of design controls for medical devices. Design Controls are an integrated set of management practices that are customer focused and ensure quality and consistency. This webinar can help you create a design control process that is a competitive strength for your company.
  • 47 Request Info

    Historical Perspective of the Part 11 Regulation

    Documented Part 11 training, as with any FDA regulation, is required for staff members who have responsibilities within the scope of the regulation.Understanding the requirements of Part 11 is critical to compliance with the regulation.Knowledge of regulatory requirements is an exercise in efficiency both efficiency in project management, and avoidance of non-compliance penalties.
  • 48 Request Info

    DHF, DMR, DHR, TF , Design Dossiers - The Requirements

    This webinar will examine the existing and proposed requiements for the U.S. FDA's DHF, 21 CFR 820.30 and now ISO 13485:2016 7.3 including its derivitive documents, the DMR and DHR. It will consider the European Union's MDD TF/DD and its transition to the EU MDR requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
  • 49 Request Info

    Learn the Essentials of Dealing with Non-Conforming Material

    Non-conforming material happens. And medical device companies must deal it. This 90-minute webinar will help you to make sense of confusing regulations and effectively deal with non-conforming material. You'll learn how to identify, segregate, control, and disposition non-conforming material. You'll learn about conducting failure investigations and requirements for correction and corrective action. Join industry expert, Susanne Manz from Manz Consulting Inc, to learn the essentials of dealing with non-conforming material.
  • 50 Request Info

    A Detailed Introduction on Statistical Process Control

    However, all production processes exhibit variation that is, no two items are identical. What method can be used to reduce such variation? The classic and still most widely used method is called SPC or "statistical process control".
  • 51 Request Info

    What you need to know to Meet FDA and International Quality Standards

    This webinar will give you an understanding of the different types of contamination inherent in compressed air and how to prevent each from affecting your particular system, It will also detail GMP standards and requirements pertaining to compressed air quality, and will discuss cause and effect, also prevention of the contamination.
  • 52 Request Info

    Compliance for Computer Systems Regulated by FDA

    The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This includes development of a company philosophy and approach, and incorporating it into the overall computer system validation program and plans for individual systems that have this capability. FDA's 21 CFR Part 11 was enacted in the late 1990s and implementation success across the pharmaceutical and other regulated industries has been mixed.
  • 53 Request Info

    How to Prepare and Manage FDA Inspections

    This course is designed to provide participants with an understanding of the purpose of FDA Inspections, the consequences of not complying with their requirements and how to prepare and manage these types of inspections. It will provide details on each topic from the course outline.
  • 54 Request Info

    Webinar on EU GDPR Deadline is Just around the Corner: Understanding Compliance for Clinical Trials for Life Sciences Companies

    Join this webinar to be better prepared to comply with new regulation, as well as understand the terms and definitions used in GDPR relevant to clinical trials. Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/EU-GDPR-Deadline-is-Just-around-the-Corner-Understanding-Compliance-for-Clinical-Trials-for-Life-Sciences-Companies-503375/MAY-2018-ES-TRAININGREGISTRY
  • 55 Request Info

    New EU Medical Device Regulation | Updated Regulation 2018

    In 2012, the Commission adopted a package of measures on innovation in health. The package consisted of a Communication and two regulation proposals to revise existing legislation on general medical devices and in vitro diagnostic medical devices. In particular, the Directives on active implantable medical devices (90/385/EEC) and on medical devices (93/42/EEC) are intended to be replaced by a Regulation on medical devices, while the Directive on in-vitro diagnostic medical devices (98/79/EC) is intended to be replaced by a Regulation on the same subject. The revisions therefore affected all kinds of medical devices including in vitro diagnostic medical devices, from home-use items like sticking plasters, pregnancy tests and contact lenses, to X-ray machines, pacemakers, breast implants, hip replacements and HIV blood tests.
  • 56 Request Info

    Biostatistics for Non-Statistician Salt Lake City Seminar 2018

    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 software’s are now available to professionals. However, these software’s 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?
  • 57 Request Info

    Preparation of FDA Submissions and Communicating with the FDA | Seminar 2018

    What do the regulations say? Navigate the FDA drug and device approval system Prepare, construct and submit well-written IND, NDA, BLA, PMA, 510(k) and IDE submissions and regulatory filings Navigate the FDA review process Identify the required regulations and guidance documents for drug and biologic submissions Use regulations and guidance documents to outline and construct a variety of drug and biologic submissions Formulate a working knowledge of regulatory submissions, publishing, and style guides
  • 58 Request Info

    SOP Development and Implementation for the FDA-Regulated Industry 2018

    One of the best ways to ensure that an organization meets its regulatory obligations is to follow SOPs. SOPs are standardized procedures and processes prepared with enough detail to ensure that tasks are performed consistently each time they are done. SOPs are also required to be in compliance with regulations and guidelines internationally, across all regulated functions. Lack of SOPs and not following SOPs are often cited in regulatory inspections as deficiencies that must be corrected. Poorly prepared SOPs or poor compliance with existing SOPs can compromise a drug development program, an effective quality system, and may result in product recalls.
  • 59 Request Info

    A Risk Based Approach to IT Infrastructure & Cloud Qualification 2018

    GxP Regulated companies are dependent on validated GxP computerized applications to conduct their day to day operations. These applications are, in turn, depended upon a qualified infrastructure that can be relied upon to provide control and regulatory compliance. The consequences of the IT Infrastructure being out of compliance can result in the failure of an entire site or geographic region being brought to a standstill while the compliance issue is resolved. It can also result in regulatory citations during a regulatory inspection as both the infrastructure be out of compliance and also cause the computerized applications that are dependent on it to be out of compliance.
  • 60 Request Info

    HIPAA Compliance | Complete, Step-by-Step Seminar 2018

    Organizations of all types and sizes continue to struggle needlessly with HIPAA Compliance. For example, HIPAA Risk Analysis - Risk Management is the basis of the HIPAA Compliance Program of every Covered Entity and Business Associate. But mandatory HIPAA Compliance Audits conducted by the Office for Civil Rights (OCR), the HIPAA enforcement arm of the U. S. Department of Health and Human Services (HHS), found 94% of Covered Entities failed the Risk Management Audit and 87% failed the Risk Analysis Audit.