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  • 21 Request Info

    6-Hour Virtual Seminar on The New EU Medical Device Regulation

    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.
  • 22 Request Info

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

    The world is swimming in data yet raw data is mostly useless without methods to turn this data into useful and actionable information. Those individuals and companies that make best use of the available data achieve a competitive advantage by optimizing their operations and making superior decisions. Companies that fail to take advantage of data are resigned to chasing rather than leading in this information age. However, most analysts and decision makers do not possess enough knowledge in statistical methods to effectively use their data and they often find it difficult to interface with statisticians at their disposal.
  • 23 Request Info

    6-Hour Virtual Seminar on Payroll Virtual Boot Camp: Wage & Hour

    This seminar concentrates on five areas of wage and hour law: paying exempt employees, calculating gross wages under the FLSA, deducting from an employee's wages, the nuts and bolts of physically paying employees and changing payroll frequencies. Why you should attend Join renowned payroll expert Vicki M. Lambert, CPP for this 5 and one-half hour "Boot Camp" format, Wage and Hour Training for Payroll Professionals! By knowing and understanding Wage and Hour requirements, you can help protect your company from what could be a major financial calamity. This includes not only how to do the basic math of calculating overtime (using the required FLSA method) but what hours must be paid for, what payment methods are legal in which states, how soon to pay an employee after closing out the timecard, and making sure exempt employees are paid on a "salary basis".
  • 24 Request Info

    6-Hour Virtual Seminar on Stress Management & Burnout Prevention in the Workplace

    Professionals are under more stress than ever evidenced by increases in demand for better services that are more efficient and thorough, higher costs, reduced staffing, and diminishing resources. Many workers are putting in longer hours and for less pay. From working overtime to simply burning the midnight oil catching up on paperwork, work industry puts a great deal of stress and fatigue on the average worker and their relationships, including family. Many professionals bear witness to workplace challenges that range from troublesome to traumatic. As a result, high stress and burnout are major hazards of any profession. This seminar focuses on understanding each of these challenges. In addition to defining and comparing these conditions, specific triggers will be explored. Participants will gain awareness of key signs and symptoms of stress and burnout, while learning how to manage stressors and their consequences.
  • 25 Request Info

    6-Hour Virtual Seminar on 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. Why you should attend Recognize regulatory requirements for batch records and batch record review Discover the essentials of batch record reviewer qualifications and training Establish a working relationship between production and quality reviewers What to do when a batch fails to meet specifications (discrepancies and deviations)
  • 26 Request Info

    6-Hour Virtual Seminar on Designing Stark Compliant Physician Compensation Models

    In this program, we will review the physician anti-referral laws (Stark I and II), provide an in-depth discussion of physician employment contracting, review the relevant Stark exceptions and discuss how physician compensation models can be in compliance with the Stark prohibitions. Why you should attend This session is designed for health care executives, physicians and other health care providers who participate in and receive remuneration from Medicare, Medicaid, and other federal health care programs such as TriCare. Several recent cases bring home the realization that Stark II (the physician anti-referral law) is alive, still with us and as viable as ever, and it can be used as the basis of a False Claims Act action.
  • 27 Request Info

    6-Hour Virtual Seminar on Effective Technical Writing in the Life Sciences

    This seminar will begin with a general discussion of technical writing and its role within the life sciences. Technical writers produce a variety of technical documents that are required to manage and direct regulated operations and to meet regulatory requirements. We will spend some time in this seminar discussing those document types, their importance, and the consequences of the messages are unclear or misunderstood. After setting the stage for this content, we delve into the writing process beginning with the audience and how the audience must be analyzed to determine the level of writing that must be employed to complete the document.
  • 28 Request Info

    6-Hour Virtual Seminar on The New EU Medical Device Regulation

    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.
  • 29 Request Info

    Useful Statistical Methods for Defining Product and Process Specifications

    Overview: Scientists, Design Engineers, and Manufacturing/Process Engineers must develop product and process specifications that ensure that products delivered to customers perform their intended functions over time. If specifications are too wide,the risks of inadequate product performance and product failures increase. If specifications are too tight, the costs to ensure conformance increase. Scientific and engineering theory, knowledge, and principles play an important role in developing specifications, but usually this must be combined with testing and data analysis to verify appropriate specifications. This webinar covers useful and important statistical methods that assist scientists and engineers in the development of appropriate product and process specifications.
  • 30 Request Info

    Secrets to Writing Effective SOPs for Medical Device QMS

    Overview: Standard Operating Procedures (SOPs) are a critical ingredient in an effective and efficient Quality Management System. SOPs are typically one of the first things an investigator asks for in an inspection. Well written SOPs send a message to the FDA and Notified Bodies that your QMS is complete, accurate, and followed. More importantly, well written SOPs ensure that your personnel can consistently and accurately follow your processes resulting in correct outcomes and quality work. This webinar will help you to write clear, unambiguous, and flexible SOPs. You will learn techniques for creating easy to read, clear, and concise SOPs that your employees can easily follow. Well written SOPs ensure that your employees understand and consistently follow processes. Well written SOPs send a message that your QMS is complete, accurate, and followed.
  • 31 Request Info

    Understanding and Applying ICH Q3A and Q3B for Control of Impurities

    Overview: This course is designed to provide participants with an understanding of the regulatory expectations for controlling impurities and degradants (including DNA reactive/potential genotoxic impurities) in drug substances and drug products. There will be ample opportunity to discuss questions and challenges from the participants. Why you should Attend: Upon completion of this course the learner should be able to: Understand regulatory expectations regarding impurities, degradants and potential genotoxic impurities in pharmaceuticals Understand what specifications will conform to regulatory expectations Develop an process for reporting impurities and addressing OOS situations
  • 32 Request Info

    Updated CE Marking Process & ISO 13485:2016 Expectations

    Overview: This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the recently developed regulation and its impact on the future compliance and registration of medical devices in the EU. It includes specific insights from direct involvement and work within the EU and the Commission's major improvement objectives to their system today. Areas of change between the prior Medical Device Directive (MDD) and the MDR will be discussed as well as expectations for how to implement ISO-13485:2016.
  • 33 Request Info

    3-Hour Virtual Seminar on Design Controls for Medical Devices

    Overview: Design Control is considered a critical process by the FDA. Yet is still a common source of 483 and Warning Letter observations. Most importantly, Design Control is critical to product quality, ensuring safe and effective products for your customers. This 3-hour 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. An effective and efficient design control process results in a predictable product development process with improved quality and compliance result. This webinar can help you create a design control process that is a competitive strength for your company.
  • 34 Request Info

    6-Hour Virtual Seminar on A Risk Based Approach To Data Integrity

    This course will provide the attendees with more detailed experience on validation / 21 CFR 11 compliance of a computer system, as well as details for activities associated with computer systems validation. Why you should attend This course is appropriate for beginner and experienced person alike. The topics will build on each other and will give you the latest trends in our heavily regulated industry and how to make it easy for yourself while still achieving data integrity. This is a very hands-on class and the attendees will be given take away templates that will enable them to build a complete package to meet Data Integrity Requirements for Computerized Systems
  • 35 Request Info

    Stress Management & Burnout Prevention in the Workplace: Strategies & Solutions

    Overview Professionals are under more stress than ever evidenced by increases in demand for better services that are more efficient and thorough, higher costs, reduced staffing, and diminishing resources. Many workers are putting in longer hours and for less pay. From working overtime to simply burning the midnight oil catching up on paperwork, work industry puts a great deal of stress and fatigue on the average worker and their relationships, including family. Many professionals bear witness to workplace challenges that range from troublesome to traumatic. As a result, high stress and burnout are major hazards of any profession.
  • 36 Request Info

    6-Hour Virtual Seminar - HIPAA - Emailing, Texting, and Personal Devices (myths vs realities)

    Overview This six-hour seminar will be going into great detail regarding you practice or business information technology and how it relates to the HIPAA/HITECH Security Rule and securing PHI in transmission. I will go through multiple examples and specific scenarios and also offer simple common-sense solutions. Areas covered will be texting, email, encryption, medical messaging, voice data, personal devices, and risk factors. I will uncover myths versus reality as it relates to this very enigmatic law based on over 1000 risk assessments performed as well as years of experience in dealing directly with the Office of Civil Rights HIPAA auditors.
  • 37 Request Info

    6-Hour Virtual Seminar on How to be HIPAA Compliant

    Overview This 6-hour webinar takes the participants through HIPAA compliance from start to compliance. The first presentation explains the history of HIPAA, why it came into being and its evolution. This covers what HIPAA is, what steps have to be performed to be HIPAA compliant and what HIPAA compliance is. It also provides definitions to key HIPAA terms, how to define a Business Associate and how to contract with Business Associates. The second part of the first presentation is an overview of how to manage the HIPAA compliance project.
  • 38 Request Info

    6-Hour Virtual Seminar on SOP Writing, Training and Compliance in the Pharmaceutical Industry

    Overview Standard Operating Procedures (SOPs) are the basis for a large part of the day-to-day training that most pharmaceutical employees are required to perform. Still, it is not widely understood the extent of the commitments we make when we write an SOP or how the writing of the SOP can have a positive or negative impact on training or job performance. For example, there is an expectation that procedures describe the most critical processes for product manufacturing and will be followed consistently, with few if any deviations. In this course you will learn the keys to writing effective SOPs, the vital connection between the documentation and training spheres, and how to maximize this connection to improve the quality of both SOPs and training.
  • 39 Request Info

    6-Hour Virtual Seminar on Statistical Process Control & Process Capability

    Overview Statistical Process Control charts have been called the Voice of the Process. Progressive manufacturers utilize control charts to "listen" to their processes so that potentially harmful changes will be quickly detected and rectified. However, not all SPC programs deliver to their highest capability as there are many elements to get right to achieve maximum utility. Highly effective SPC programs combine technical competencies, such as using an appropriate chart and sample size for the application, with effective management techniques such as enabling operator buy-in and involvement. This webinar provides a comprehensive introduction to SPC methods and tools to help you deploy an effective SPC program.
  • 40 Request Info

    6-Hour Virtual Seminar on A Risk Based Approach To Data Integrity

    This course will provide the attendees with more detailed experience on validation / 21 CFR 11 compliance of a computer system, as well as details for activities associated with computer systems validation. Why you should attend This course is appropriate for beginner and experienced person alike. The topics will build on each other and will give you the latest trends in our heavily regulated industry and how to make it easy for yourself while still achieving data integrity. This is a very hands-on class and the attendees will be given take away templates that will enable them to build a complete package to meet Data Integrity Requirements for Computerized Systems