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  • 161 Request Info

    FDA's enforcement of 21 CFR part 11 compliance

    Overview: This presentation will cover the scope, status and results of the surveillance inspections and what they may mean for the future of 21 CFR Part 11. This will enable you to determine whether your company is subject to the most common violations so you can take action to have a better inspection outcome. In December 2010 FDA started the Part 11 inspection initiative. While originally the initiative was supposed to last 3-6 months, it has now turned into an ongoing program with Part 11 related issues being part of most future inspections. At the beginning of the initiative FDA made it very clear that Part 11 is in effect and is enforced according to the original Part 11 and the Guidance from 2003. In the meantime FDA officials reported about key findings. For example, George Smith who heads up FDA's Part 11 working group gave an update with examples of violations.
  • 162 Request Info

    Computer System Validation (CSV) for FDA-Regulated Computers

    Overview: FDA requires that all computer systems used to produce, manage and report on GxP (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules. This webinar will leave you with the information needed to plan, execute and document a computer system validation effort that meets FDA compliance standards. You'll learn about the various computer system validation deliverables and how to document them through the entire process. You will learn about what must be done to ensure the system remains in a validated state. In addition, you'll learn all about how to create and maintain good FDA-compliant documentation using a strategic approach based on the System Development Life Cycle (SDLC) Methodology.
  • 163 Request Info

    Standard Operating Procedure (SOP) and Work Instructions (WIs)

    Overview: This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow. It will begin with a strategic view of SOPs in a company and how SOPs can help streamline operations in addition to ensuring regulatory compliance. This will be followed by explanation on how to get from regulations to the SOP. Finally, Best Practices for creating, implementing and maintaining SOPs using a risk based approach and getting SOPs ready for inspection will be presented.
  • 164 Request Info

    US Regulatory Submissions and Publishing 101: Keys to Success

    Overview: Effective regulatory strategy, like product design, requires "quality-by-design" approach and planning throughout the product development lifecycle. For pharmaceutical, device, and biotechnology companies, understanding how to effectively design and manage a regulatory submission can lead to a more efficient application development process and greatly increase the likelihood of marketing authorization.
  • 165 Request Info

    Requirements and Compliance Processes for Life Sciences

    Overview: This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan. The course will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in Japan. Content will also include descriptions of the methods by which regulators in the corresponding agencies process filings and registrations and what is expected in the authorization and dossier maintenance of licensed products.
  • 166 Request Info

    Business & Practitioner Resilience in Clinical Practice

    This training introduces and discusses resilience in healthcare practice in five general areas. Each of the areas or modules is extremely important to the success and continued growth of your practice. Regardless of whether you are a general medical practitioner or a specialist in practice, or whether you are in a solo or group practice, working diligently and dealing effectively with ongoing adversity is your key to a more resilient practice.
  • 167 Request Info

    Understanding Autism Spectrum Disorder (ASD): Preparing Students to Transition to College and Succeed

    This webinar will identify the range of individual characteristics displayed by students on the Autism Spectrum, explain what happened to Asperger's Syndrome, and review the challenges of college life for students with ASD. Participants will learn practical strategies to assist, coach, and support students on the Autism Spectrum as they transition to living independently and are stretched academically, socially, and personally. At the end of this program, participants will have a better understanding of Autism Spectrum Disorder and how they can help college students on the Autism Spectrum achieve success.
  • 168 Request Info

    3-Hour Virtual Seminar - Burning Up While Burning Out - Compassion Fatigue Awareness & Burnout Prevention for Practitioners

    Healthcare professionals bare witness to human suffering on a routine basis and are constantly reminded that tragedy, pain, and challenge often loom large in the midst of helping patients heal. As a result, compassion fatigue and burnout are major hazards of the profession that are becoming far too common. This seminar focuses on understanding each of these challenges, their similarities and differences. In addition to defining and comparing these conditions, specific triggers will be explored. Participants will gain awareness of key signs and symptoms of compassion fatigue and burnout, while learning how to manage stressors and their consequences. Specific attention will be given to physical, emotional/mental and behavioral symptoms.
  • 169 Request Info

    HIPAA Breach - Or Not? How to Find Out & What to Do

    This webinar explains the inter-connected Breach Notification Rule requirements of Covered Entities and Business Associates when a Business Associate or Subcontractor Business Associate suffers a Breach. And it covers the special, more restrictive compliance requirements when a Business Associate or Subcontractor is an Agent under the Federal Common Law of Agency - including how to avoid creating an Agency relationship by mistake. This webinar for HIPAA Covered Entities and Business Associates explains the 5 Steps of HIPAA Breach.
  • 170 Request Info

    Upcoming HIPAA Audits - How to Avoid and Be Prepared

    We will be discussing some of the changes taking place in Washington with the Health and Human Services in regards to the enforcement of the HIPAA laws already on the books. I will go over some of the new changes affecting covered entities and business associates. I will also be discussing factors might cause an unwanted visit or letter from the Office of Civil Rights and how to prepare for the audit and deal with the Feds.
  • 171 Request Info

    Fraud & Abuse,Stark & Anti-Kickback Issues

    The presentation will provide an overview of the Federal Stark and Anti-Kickback laws and corresponding regulations including the history and purpose of these laws. The presenter will provide the background upon which these laws were determined to be necessary and developed. The attendees will be provided with an overview and description of the laws, why they were instituted, what they do and do not cover and who they are and are not applicable to. Once the basic constructs of the laws themselves are reviewed, the presenter will then go over the most common exceptions to these laws. Exceptions include specific scenarios in which the law allows physicians, practices and providers to participate in activities that may otherwise be deemed prohibited under both laws.
  • 172 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.
  • 173 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.
  • 174 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.
  • 175 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.
  • 176 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.
  • 177 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.
  • 178 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.
  • 179 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.
  • 180 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.