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Courses

  • 1 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.
  • 2 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".
  • 3 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.
  • 4 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)
  • 5 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.
  • 6 Request Info

    6-Hour Virtual Seminar on The EU Clinical Trial Regulation - EU Filings & Registrations

    This course covers the requirements for conducting Clinical Studies across the EU via the requirements of the EU Clinical Trial Regulation (for Drugs & Biologics). The course also covers recent updates on EU-GCP associated with the new regulatory framework and highlights of the new EU Pharmacovigilance Directive, as it relates to studies and helpful tips into working with the European regulators. The webinar covers the impending changes coming with the EU Parliament passage of the EU Clinical Trial Regulation, which will affect all trials conducted across the EU [new and ongoing].
  • 7 Request Info

    6-Hour Virtual Seminar on Transition from Peer to Supervisor

    Today's workforce is experiencing high turnover and disengaged employees. It is a known fact that employees quit managers- to avoid turnover it is critical to have the appropriate skills to retain employees. Transition from a Peer to Supervisor can be very difficult for most newly promoted supervisors. Many are not equip with the tools to successfully transition. This seminar will equip newly promoted supervisor with tools and techniques to decrease turnover, increase employee engagement and increase employee productivity. Why you should attend New supervisors will feel empowered to hit the ground running with the skills learned in this seminar.Be ready to explore the importance of leading with impact, learn how to bring your best self to the job, while adopting new skills to successfully transisiton. This 6- hour seminar will help participants avoid common pitfalls new supervisors encounter and also learn the secrets of managing people.
  • 8 Request Info

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

    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.
  • 9 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.
  • 10 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.
  • 11 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.
  • 12 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.
  • 13 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
  • 14 Request Info

    Preventing Human Error in the Life Sciences

    Overview: This webinar will explore the true causes and nature of human error, how human error should be investigated, how human error relates to human performance, and the difference between real human error and systems, process, and management deficiencies. Why you should Attend: Human Error occurs in all settings. In the world of pharmaceutical manufacturing, the result of that error can result in loss of product or at the most extreme, injury to patients. Human is a frequent occurrence in pharmaceutical manufacturing. It occurs even when every obvious preventive actions have been employed such as effective compliance documentation development and training.
  • 15 Request Info

    Validation and Use of Excel Spreadsheets in FDA Regulated Environments

    Overview: Excel® Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation. Regulations such as HIPAA, Sarbanes Oxley Act and FDA's GxP and 21 CFR Part 11 require users of software and computer systems to demonstrate and document data accuracy, integrity and confidentiality. Out-of-the box Excel® has not been designed for regulated environments. However, with a good knowledge of Excel® capabilities combined with good procedures and practices on how to validate and use Excel® requirements can be met. For example, the FDA is widely using Excel® and complies with its own regulations.
  • 16 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.
  • 17 Request Info

    Mastering Excel Pivot Tables

    Overview: PivotTable capabilities are enormous; among its many tools and features. You will learn the following in this webinar, The quickest and best ways to create PivotTables and Pivot Charts, including these capabilities: The following subjects will be covered in detail: How to compare two or more fields in a variety of layout styles How to sort and filter results How to perform ad-hoc grouping of information How to use Slicers instead of filters to identify which field elements are displayed How to drill down to see the details behind the summary How to categorize date/time data in multiple levels How to create a Pivot Chart that is in sync with a PivotTable How to add calculated fields to perform additional analysis How to hide/reveal detail/summary information with a simple click How to deal with dynamic source data and the "refresh" concept How to create a PivotTable based on data from multiple worksheets
  • 18 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.
  • 19 Request Info

    De-Identification of PHI under HIPAA - Follow the Guidance to Avoid Penalties

    Overview: Today health information needs to be shared more than ever, but how can that be done most easily within the limits of HIPAA? One way is to de-identify the information. Once PHI has been de-identified, it is no longer protected under HIPAA and may be shared freely without limitation. The problem is that it is not easy to truly de-identify information and if it is not done correctly, the sharing of the information may be considered a breach that requires reporting to HHS and the potential for penalties and corrective action plans.
  • 20 Request Info

    Structuring and Auditing Physician Medical Director and Administrative Arrangements

    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 administrative 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.