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  • 1 Request Info

    MDUFA IV - An Introduction

    In this webinar speaker will review the user fees themselves in more detail and discuss the performance goals established as a result. And finally, she will devote the bulk of this presentation to highlighting the program areas addressed with the passage of MDUFA IV.
  • 2 Request Info

    FDA's New Enforcement of 21 CFR Part 11 2018

    FDA continues to enforce Part 11 through its ongoing Part 11 inspection and enforcement program. Just in the last 3 years FDA issued more than 30 warning letters with Part 11 related observations. Citations are related to inadequate integrity, security and availability of electronic records, including data manipulation. There are many questions about the ongoing inspection and enforcement program, e.g., what inspectors are looking at, what are major findings and what are the FDA expectations about follow up.
  • 3 Request Info

    A Guide to Building a Safety Culture 2018

    The Behavioral Based Safety system (BBS) is a valued tool used in conjunction with other safety and health aids, such as, job hazard analysis, fault tree analysis, audits, and inspections. The BBS focuses on the behavior of the worker which is measurable and observable, unlike a person's attitude. When behavior which can cause accidents and organizational loses are observed, the BBS system will give aids to the safety officer in coaching safe behavior. The final output of an effective BBS system is to create a safety culture.
  • 4 Request Info

    Validation of Non-Product Software 2018

    In this webinar We will explain the role of Risk Management in Non-Product Validation, understanding how to avoid major mistakes when validating software to FDA standards, This webinar will review the validation planning process with emphasis on avoiding common pitfalls, The attendee should leave the presentation confident in their ability to improve the level of validation success.
  • 5 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.
  • 6 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.
  • 7 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.
  • 8 Request Info

    Documentation Challenges in Behavioral Health

    Overview: This webinar will provide participants with an overview and in-depth examination of compelling documentation issues in behavioral health. Dr. Frederic Reamer will explore high-risk ethical issues and practical strategies designed to protect clients and practitioners. The webinar will explore a series of documentation challenges and explore practical steps that professionals can take to manage ethical issues skillfully and minimize risk. Key topics will include: The content of documentation Documentation wording Credibility issues related to documentation Accessing confidential records Record retention Responding to subpoenas Managing records in integrated health settings Dr. Reamer will discuss relevant ethical standards; statutes, regulations, and case law; and national practice standards related to documentation.
  • 9 Request Info

    Neuroscience Applications to Mental Health Treatment

    Overview: Over the past couple of decades there has been an exciting merging of psychotherapy and neuroscience research that is revolutionizing clinical practice. Cognitive, affective, social, and positive neuroscience research provides profound insight into the brain changes we are capable of producing. We are beginning to learn, through this research, how to enact these changes through the practice of psychotherapeutic techniques that target and improve the functioning of specific brain structures. This webinar, led by clinical expert Dr. Jennifer Sweeton, shares the most up-to-date research discoveries and teaches highly effective psychotherapy techniques clinicians can begin using tomorrow. Why should you Attend: Neuroscience research is providing insight into why, when, and with whom specific psychotherapeutic approaches may be beneficial to therapy clients.
  • 10 Request Info

    HIPAA vs. SAMHSA 42 CFR Part 2

    Overview: This session focuses on the issues of managing health information when it may involve substance abuse treatment information. HIPAA allows a number of disclosures without consent that SAMHSA prohibits without consent. First we will explain how HIPAA relates to information management and release and explain the processes required for various releases of information under the HIPAA rules, including release according to individual access requests, and under HIPAA authorizations. When substance abuse treatment information is involved, first you need to understand how to identify it. We will discuss how to make it distinguishable from "regular" health information, so that the appropriate extra protections can be provided.
  • 11 Request Info

    3-Hour Virtual Seminar on HIPAA 2018 and Beyond

    Overview: This three hour webinar will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order as HIPAA is now fully enforced and the government is not using kid gloves any more. It will also address major changes under the Omnibus Rule, Trump administration, and any other applicable updates for 2018 and beyond. There are an enormous amount of issues and risks for covered entities and business associates these days - we will speak to the most common violations and fines - and how to best avoid fines and headaches altogher. I will speak on specific experiences from over 18 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.
  • 12 Request Info

    New Guidance on De-Identifying Protected Health Information under HIPAA

    Overview: This webinar will be addressing the ins and outs of identifying what is and what is not PHI, proper ways to disclose this information, common sense security methods, what we can and can't do under HIPAA relating to disclosures, and how to properly investigate a breach (or a suspected breach). We will also 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 Omnibus Rule and any other applicable updates relating to protected health information Additional areas covered will be texting, email, encryption, medical messaging, voice data and risk factors as they relate to IT. The 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 over regarding the do's and don'ts with HIPAA -I want to add clarity for compliance officers.
  • 13 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.
  • 14 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.
  • 15 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.
  • 16 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.
  • 17 Request Info

    Token Economies to use in a Hospital or Community Setting

    Overview: In hospitals, schools, group homes and in private residential settings, behavior problems are one of the most challenging areas to address. Issues such as physical aggression, self-injury and poor communication and compliance are the very barriers that can keep one from attaining personal independence. Improvements in behavior that free an individual from restrictive methods and punishing contingencies, as well as enable one to live life as he or she chooses, are always a step forward. The problem with many methods of improving behavior is that it is difficult to reinforce appropriate behavior in a timely manner. Conversely, destructive and counter-productive behavior is often reinforced (in surprising ways) much sooner than the opposite. One of main problem with behavior improvement programs is the reinforcement (for appropriate behavior) comes too far after the time of the replacement behavior.
  • 18 Request Info

    Software and Device Changes and the 510(k)

    The first guidance document clarifies key terms and provides insight as to how a risk assessment can help medical device manufacturers to evaluate whether a new 510(k) is required. Examples of device changes and recommendations for documenting a company's decisions are provided. FDA provides a series of flowcharts and questions that can serve to guide medical device manufacturers to come to a conclusion as to whether a new 501(k) is necessary.
  • 19 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.
  • 20 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.