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  • 121 Request Info

    How People with Depression Think - How to Help

    Overview: Humans are thinking machines and most people have similar thought processes. Most people have reasonable, measured, moderate thoughts. And while there are many variations on this theme, these thoughts occur on a bell curve with most people being in the meaty part of the curve. Those with major depressive disorder (major depression), however, often have very extreme thoughts and their thought processes often exist on the very far ends of the bell curve. This can make understanding how a person with major depression acts very challenging as these actions are driven by thought processes the average person doesn't experience. While these thoughts may seem “crazy” at first, it's important to realize that these thoughts are simply an extreme part of the human experience that do fall along a continuum that is experienced by everyone.
  • 122 Request Info

    Structuring and Auditing Physician Employment Agreements to Comply with the Stark Law and Anti-Kickback Statute

    Overview: In this session Mr. Wolfe will provide an overview of the Stark Law and Anti-Kickback Statute. He will also discuss best practices for structuring, negotiating physician employment agreements. The webinar will focus on regulatory requirements,key provisions, valuation considerations and potential pitfalls that should be avoided. Why should you Attend: As health care organizations and physicians develop their employment arrangements, they must ensure the employment and compensation structures are defensible under the Stark Law and Anti-Kickback Statute. In this webinar Mr. Wolfe will describe how to develop employment structures and financial terms that comply with the technical regulatory requirements and key tenets of defensibility (fair market value, commercial reasonableness, etc.) to manage risk.
  • 123 Request Info

    Key Considerations When Buying or Selling Physician Practices

    Overview: In this session Mr. Wolfe will provide an overview of the Stark Law, including its 2016 changes. He will also discuss best practices for negotiating and drafting physician practice acquisition arrangements on behalf of health systems, hospitals, medical groups and physician practices. The webinar will focus on regulatory requirements, key provisions, valuation considerations and potential pitfalls that should be avoided. Why should you Attend: As health care organizations and physician practices pursue acquisition strategies and transition to more innovative post-transaction models, they must manage their compliance and enterprise risk by ensuring any new arrangements are defensible under the Stark Law.
  • 124 Request Info

    What is the Government Looking for In a HIPAA Audit

    This lesson 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.
  • 125 Request Info

    When to Submit a 510(k) for a Change to an Existing Device

    Overview: This presentation, will aid manufacturers of medical devices who intend to modify a 510(k)-cleared device or a preamendments device subject to 510(k) (i.e., "existing devices") during the process of deciding whether the modification exceeds the regulatory threshold of 21 CFR 807.81(a)(3) for submission and clearance of a new 510(k).
  • 126 Request Info

    Essentials of Validation - IQ, OQ, PQ

    Overview: Validation is an important element of the Quality System Regulations and ISO13485. This course will cover the requirements the essentials of validation. You'll learn about what processes needed to be validated and what steps you need to take to validate processes. You'll learn the essentials of validation planning, protocol writing, and change management We'll cover the steps of Installation Qualification (IQ),Operational Qualification (OQ), and Performance Qualification (PQ) including tips and best practices.
  • 127 Request Info

    3-Hour Virtual Seminar - Good Pharmacovigilance Practice

    Refund Policy This course aims to provide basic training for those concerned with pharmacovigilance, This course has been planned to provide you with the essential skills and tools to prepare and host a regulatory inspection and to facilitate the response and follow-up to the inspection outcome, findings (483s) and the necessary Corrective Actions and Preventive Actions (CAPA).
  • 128 Request Info

    Validation of Laboratory and Process Analysis Instrumentation

    Overview: How to choose/make standards: Lab-based standards are most often synthetic, with final forms tested for extraction of all the analyte Process samples are most often final product, scanned spectroscopically, then analyzed via a referee method. Process stds may be made synthetically, but several precautions need to be taken.
  • 129 Request Info

    European Data Protection Regulation - 2018 Implementation

    Overview: On 4 May 2016, the official texts of the Regulation and the Directive have been published in the EU Official Journal in all the official languages. While the Regulation will enter into force on 24 May 2016, it shall apply from 25 May 2018. The Directive enters into force on 5 May 2016 and EU Member States have to transpose it into their national law by 6 May 2018.
  • 130 Request Info

    Verification vs Validation-Product, Process or Equipment and QMS Software

    Overview: The verification and validation of regulated software is coming under increased scruinty by the U.S. FDA.This webinar will address the use of the FDA, GAMP, 21 CFR Part 11,"Electronic Records"/"Electronic Signatures", IEC 62304, and other applicable industry software validation models, coupled with the ISO 14971/ICH Q9 Product Risk Management models, to plan, structure, run, and document acceptable software validations.
  • 131 Request Info

    3-Hour Virtual Seminar on Data Integrity - FDA's Latest Thinking

    Overview: This webinar will give you the tools that you need to ensure that you understand data integrity issues and best practices for ensuring data integrity at your company. Why should you Attend: The FDA is increasingly focusing on data integrity issues, including data manipulation, when conducting facility inspections. Concerns over data integrity issues have resulted in the agency adding companies to the for-cause inspection list, and the FDA has found questionable data during in a significant number of these for-cause inspections. The FDA is noticing some electronic data manipulation in parts of its inspection program and is focusing on training its investigators to be more alert to data manipulation, Branding said.
  • 132 Request Info

    Managing and Controlling the Project - Project Management

    The subject of this webinar is building the project team, The key to achieving success with your project is the people you assign to it, how well you develop the team, and sustaining team member's ongoing commitment to the successful completion of the project, Also you will learn This process includes developing team and individual team member goals, determining the team's operating processes, and building strong team member relationships.
  • 133 Request Info

    Reducing Training Related Errors (Human Error Trainings)

    This course will provide insights into current knowledge of human error and how it can be reduced, The course will provide hands-on experience of practical error reduction techniques, using real-life case studies, You will also gain an understanding of the underlying causes of human error and how to reduce its occurrence by changing the culture of the organization and changing the design of the processes.
  • 134 Request Info

    Computer System Validation 2018 Fundamentals

    This session will address the specific way of documenting your computer system validation work to ensure it meets FDA requirements and can pass an inspection, also this webinar will help you understand the FDA's requirements for good documentation, including how to handle change control and the importance of audit trails, you will learn how to create and maintain good documentation that meets FDA compliance standards.
  • 135 Request Info

    What's Changing for Life Science Product License Holders (BREXIT)

    Overview: The United Kingdom submitted its' notification on 29 March 2017 to withdraw from the European Union. This means that unless a withdrawal agreement establishes another date, all EU primary and secondary Laws cease to apply to the UK from 30 March 2019 going forward. The UK, by definition would become a "third country". Preparing for the withdrawal doesn't just involve the Healthcare Authorities, but every manufacturer and /or license holder of a pharmaceutical, biologic, medical device or combination product in the UK and EU.
  • 136 Request Info

    Information Technology - Control Procedures in Regulated Industries

    In this webinar, change control procedures within quality management systems (QMS) for documentation and information technology systems will be discussed, And you will learn about change control process and change control procedures as they apply to documentation and information technology systems in regulated industries.
  • 137 Request Info

    FDA New Draft Guidance on (Software) and Device Changes 510k

    Overview: A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR 807.92(a)(3)) that is not subject to PMA. The FD&C Act and the 510(k) regulation (21 CFR 807) do not specify who must submit a 510(k). Instead, they specify which actions, such as introducing a device to the U.S. market, require a 510(k) submission. You will learn about Substantial Equivalence to support a 510(k) submission.
  • 138 Request Info

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

    Overview: This webinar will take you through the primary sources of compressed air contamination. It will also detail GMP standards and requirements pertaining to compressed air quality. Why should you Attend: Compressed air is often overlooked as a potential source of clean room and product contamination. 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.
  • 139 Request Info

    HIPAA vs. SAMHSA 42 CFR Part 2

    Overview: This lesson will be addressing how practice/business managers (or compliance offers) need to ensure their organization is complying with the Federal Substance Abuse and Mental Health Administration (SAMHSA) regulations (42 CFR Part 2) and how this differs from the HIPAA (Health Insurance Portability and Accountability Act) Privacy and Security Regulations. Both regulations carry significant civil and even criminal penalties if not complied with. Both regulations are now being enforced proactively by the Federal government. Both regulations if not complied with can lead to catastrophic legal consequences on state laws of negligence and invasion of privacy if not complied with.
  • 140 Request Info

    Parenting the Defiant Child-Adolescent

    Overview: In this webinar we will discuss how to effectively parent a defiant child/ to turn those poor attitudes and "no's" into more compliance, and more of a working relationship between the child/adolescent and parent. Why should you Attend: In treatment, parents are so important when working with children and/or adolescents. We can do a lot of work within our specific setting, however a lot of times success depends highly on the parents. Sometimes engaging the parents can prove it's own set of challenges. This webinar will provide helpful, simple to use tips regarding parenting, especially parenting a defiant child/adolescent. This webinar will address how to talk to parents about communicating effectively, gain understanding about where children/adolescents are at developmentally, and how to implement fun into the parenting/family dynamic.