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Courses

  • 1 Request Info

    Hiring and Selection Mastery

    Hiring and selection is one of the most important business decisions a hiring manager will make. Adding a new member to a team will drastically change how that team works and functions. PXT Select provides a useful way to help hiring managers understand their candidates at a deeper level. The insights from this tool, combined with the candidate's experiences as relayed through the interview and their resume will help ensure that your next hire is successful. In our PXT Select Expert Practitioner, learners will understand how they can use PXT Select to enhance their hiring process. This tool provides insights from helping an organization select the right candidate, the right candidate for hiring, the right employee for promotion, and how to help any employee improve in their role. This certification costs $1,995.
  • 2 Request Info

    Emotional Intelligence Certified Coach

    Emotional Intelligence is needed more than ever. Individuals who are able to recognize their emotions and make changes in their behavior to match what is needed in a emotional situation are better prepared to deal with the situation. Our Emotional Intelligence Certified Coach training is for anyone who wants to train or coach individuals and teams in improving their emotional intelligence. This training focuses on using the EIQ-2 assessment. Register for this training for only $1,795 (includes facilitation materials).
  • 3 Request Info

    Five Dysfunctions of a Team

    The Five Dysfunctions of a Team has showcased how teamwork is still the most ultimate competitive advantage. In 2015, Patrick Lencioni teamed up with the publisher of Everything DiSC to take his training and add a behavioral component to this powerful training program. Lencioni's training is now called the Five Behaviors of a Team and accreditation for this program is now available. In this five-week, online program, trainers and coaches will complete self-paced pre-work and join weekly live sessions where they dig into Lencioni's team-based model. Learners will walk away with a better understanding of the model and how to conduct a successful program. Facilitation materials are included in the cost of this program. Register now for $3,695.
  • 4 Request Info

    Mobile Apps as Medial Devices

    Overview: Some of these new mobile apps / software functions are specifically targeted to assisting individuals in their own health and wellness management. Others are targeted to health care providers as tools to improve and facilitate the delivery of patient care. These software devices include products that feature one or more software components, parts, or accessories, as well as devices that are composed solely of software. Certain software functions / mobile apps that are device functions can pose potential risks to public health, and these are the subject of FDA concern and focused regulation. Mobile medical apps, as defined here, include only those mobile apps that: Meet the definition of a device Intended to be used as an accessory to a regulated medical device Intended to transform a mobile platform into a regulated medical device. What are they as defined by the FDA, what are not? Requirements? Cybersecurity, documentation and validation requirements
  • 5 Request Info

    Data Integrity: Compliance with 21 CFR Part 11, SaaS-Cloud, EU GDPR

    Overview: This webinar describes exactly what is required for compliance with Part 11 and the European equivalent Annex 11 for local, SaaS/Cloud hosted applications. It explains how to write a Data Privacy Statement for compliance with EU General Data Protection Regulation (GDPR). What the regulations mean is described for all four primary compliance areas: SOPs, software features, infrastructure qualification, and validation. It gets you on the right track for using electronic records and signatures to greatly increase productivity and ensure compliance.
  • 6 Request Info

    How Will FDA's New Approach to CSV Make Implementations Easier?

    Advancements in technology have forced organizations to rethink business models. Once controlled and orderly, these organizations are now more chaotic and complex, serving patients and customers that are better informed and with higher expectations than ever before. Work practices and tools must change to meet these challenges.
  • 7 Request Info

    Effective Standard Operating Procedure (SOPs) Development

    Overview: Standard Operating Procedures (SOPs) are a regulatory requirement for industries that are governed by the FDA and other world health authorities. Currently, there is no guidance on how to develop or manage the SOP creation or the SOP quality system. Why you should Attend: Consequently, SOPs are frequently written in a way that makes compliance difficult or downright impossible. In many cases, this sometimes leads to subpar documents that come to light during a regulatory inspection. In this webinar you will learn how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is reproducible and easy to follow.
  • 8 Request Info

    Best Practices in Preparation for an FDA Computer System Audit

    Overview: As a "GxP" system, following Good Manufacturing, Laboratory and Clinical Practices, the computer system must be validated in accordance with FDA requirements. If electronic records and/or electronic signatures (ER/ES) are incorporated into the system, FDA's CFR Part 11 guidance on ER/ES must be followed. This webinar will focus on the key areas that are most important, including security and data integrity. Implementing and following the System Development Life Cycle (SDLC) methodology is the best approach for computer system validation and maintaining data integrity.
  • 9 Request Info

    6-Hour Virtual Seminar - 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. This webinar will analyze each of these necessary elements of the batch record review process.
  • 10 Request Info

    4-Hour Virtual Seminar on Credit Risk Management- Principles and Practices, Tools and Techniques

    A strong credit culture: Focuses the organization-everyone on the same page Reduces organizational conflict and confusion-priorities Minimizes need for rigid controls Supports commitment to the organizational vision and mission Adds to the organization’s bottom line and enhances shareholder value
  • 11 Request Info

    6-Hour Virtual Seminar on EU Regulatory Affairs strategy during development of medicinal products

    The main document from a regulatory perspective in the development of a medicinal product is the regulatory plan. In this Seminar it is explained how to write the regulatory plan, and which aspects to consider. The regulatory plan describes the regulatory strategy, as well as pricing and reimbursement issues in your development. Orphan Medicinal Products will be discussed, and the advantages of having a status as an orphan medicinal product will be explained. Incentives for the development of orphan medicinal products have been available in the United States of America since 1983 and in Japan since 1993, and also the EU offers a range of incentives to encourage the development of these medicines.
  • 12 Request Info

    6-Hour Virtual Seminar on Moving From An Operational Manager to A Strategic Leader

    Gain the insights and skills to know where your business stands today and where it’s heading tomorrow. In today’s unpredictable business environment, strategic leadership is not just for top management alone. It’s for: Managers who may be managing their entire team remotely, particularly for the first time Managers who want to increase their competitive advantage by anticipating their customers’ priorities, needs and expectations Managers who want to distinguish operational data from strategic data, creatively develop sources of information and increase their staffs’ flexibility and responsiveness Managers who want to broaden their perspective, improve flexibility without compromising quality and increase their department’s value to the organization
  • 13 Request Info

    6-Hour Virtual Seminar on Biostatistics for the Non-Statistician

    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. Why you should attend 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?
  • 14 Request Info

    6-Hour Virtual Seminar on Combination Products

    This seminar provides Professionals working in this area with: A thorough understanding of the complexities involved Covers all the relevant regulations and guidelines Gives real life examples of how to register and maintain various types of combination products Interfaces: Change Management and LCM Compliant safety reporting for combination products Documentation requirements and interfacing
  • 15 Request Info

    4-Hour Virtual Seminar on Transformational Leadership - The Ultimate Leadership Course

    The Bulk Of What Is Being Taught About Leadership In Universities Today Is Based On Old B.S. (“Belief Systems”). These Old, Outdated Ideas Will Not Take You Or Your Business To The Next Level. This Course Will Give You Cutting-Edge Tools, Strategies And Techniques That Are Specifically Designed To Make You A Modern Leader For The New Millennium. Inside This Course You Will Learn From Celebrity Trainer & CEO “Prof. Paul” Who Teaches The Little-Known Secrets That Top Leaders Use To Rise Above The Rest. Top CEOs And Team Leaders Use These Tools To Get Impressive Results … Now You Can Too.
  • 16 Request Info

    6-Hour Virtual Seminar - Cracking the Code to Healthcare Billing, Coding and Reimbursement

    This course covers the fundamentals of medical billing, coding, and reimbursement by explaining how all of these components work together. Emphasis will be placed on the practical application of the latest industry knowledge and standards, with the goal of helping those who work with medical claims and claims data stay ahead of the game. Participants will learn about the following: The claim flow process from registration through adjudication and payment How physicians and hospitals set and manage charges Critical data elements on the two major claim forms and what they mean How and why the major coding systems are utilized How various reimbursement methods are used by payors
  • 17 Request Info

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

    Overview 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. This webinar will analyze each of these necessary elements of the batch record review process.
  • 18 Request Info

    4-Hour Virtual Seminar on Credit Risk Management- Principles and Practices, Tools and Techniques

    Overview A strong credit culture: Focuses the organization-everyone on the same page Reduces organizational conflict and confusion-priorities Minimizes need for rigid controls Supports commitment to the organizational vision and mission Adds to the organization’s bottom line and enhances shareholder value
  • 19 Request Info

    6-Hour Virtual Seminar on EU Regulatory Affairs strategy during development of medicinal products

    Overview The main document from a regulatory perspective in the development of a medicinal product is the regulatory plan. In this Seminar it is explained how to write the regulatory plan, and which aspects to consider. The regulatory plan describes the regulatory strategy, as well as pricing and reimbursement issues in your development. Orphan Medicinal Products will be discussed, and the advantages of having a status as an orphan medicinal product will be explained. Incentives for the development of orphan medicinal products have been available in the United States of America since 1983 and in Japan since 1993, and also the EU offers a range of incentives to encourage the development of these medicines.
  • 20 Request Info

    6-Hour Virtual Seminar on Moving From An Operational Manager to A Strategic Leader

    Overview Gain the insights and skills to know where your business stands today and where it’s heading tomorrow. In today’s unpredictable business environment, strategic leadership is not just for top management alone. It’s for: Managers who may be managing their entire team remotely, particularly for the first time Managers who want to increase their competitive advantage by anticipating their customers’ priorities, needs and expectations Managers who want to distinguish operational data from strategic data, creatively develop sources of information and increase their staffs’ flexibility and responsiveness Managers who want to broaden their perspective, improve flexibility without compromising quality and increase their department’s value to the organization