Medical Devices

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Courses

  • 1 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.
  • 2 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.
  • 3 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.
  • 4 Request Info

    6-Hour Virtual Seminar - Medical Claims Boot Camp - Cracking the Code

    Overview 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
  • 5 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.
  • 6 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.
  • 7 Request Info

    4-Hour Virtual Seminar on Good Laboratory Practices (GLPs)

    The objective of this webinar is to compare and contrast between Good Laboratory Practices and Good Manufacturing practices Why you should attend Good Laboratory Practices (GLPs), 21 CFR part 58 are not set of guidelines but they are regulations for conducting nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products such as food and color additives, human and animal drugs, medical devices for human use, biological products and electronic products that are regulated by the FDA.
  • 8 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.
  • 9 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.
  • 10 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".
  • 11 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)
  • 12 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.
  • 13 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.
  • 14 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.
  • 15 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
  • 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

    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.
  • 18 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.
  • 19 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
  • 20 Request Info

    6-Hour Virtual Seminar on 21 CFR Part 11 Compliance for Computer Systems Regulated by FDA

    The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This includes development of a company philosophy and approach, and incorporating it into the overall computer system validation program and plans for individual systems that have this capability. FDA's 21 CFR Part 11 was enacted in the late 1990s and implementation success across the pharmaceutical and other regulated industries has been mixed. There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record.