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Courses

  • 81 Request Info

    Seminar on Supplier Management for Medical Device Manufacturers

    Supplier selection and management is one of the critical issues for medical device manufacturers. Suppliers provide materials and services to the device manufacturer, which means that they can be critical to performance and delivery of your device. Neither the FDA nor your notified body regulates your suppliers (with a few exceptions). They expect you to have an effective process to ensure your suppliers perform in the regulatory environment. Quick Contact: NetZealous DBA as GlobalCompliancePanel Phone: 1-800-447-9407 Fax: 302-288-6884 Email: support@globalcompliancepanel.com
  • 82 Request Info

    Seminar on How to build a complete Safety, Health & Environment Management System through Standards & Practices

    A management system, by definition, is a process by which a function or functions are carried out in an organization by a series of hierarchal documents that are prescriptive, and set a particular path on which the organization manages its day-to-day operations. A management system can be for one function, but more often than not, it incorporates many functions. Functions like accounting, engineering, banking, etc. have their own management systems, and the Safety, Health and Environmental, as well as Training and Security should have their own management system. This brings efficiency, consistency, cost effectiveness and timeliness to the entire process. Quick Contact: NetZealous DBA as GlobalCompliancePanel Phone: 1-800-447-9407 Fax: 302-288-6884 Email: support@globalcompliancepanel.com
  • 83 Request Info

    Seminar on Writing and Enforcing Effective SOPs

    Writing SOPs or procedural documents can be challenging at times. However, writing SOPs is overall a straightforward process. However, enforcing what you already created and implemented in the pipeline is another story. The term SOP is very obvious. We have seen "clearly written description of how specific tasks are to be done." Another satisfactory definition would be "detailed written instructions that achieve the uniformity of the performance of a specific function." Is the firm doing what the regulations specify? Is the firm doing what their procedures specify? If you are medical device or a pharmaceutical manufacturer, these definitions come as no surprise because when it comes to FDA regulations and guidance documents "establish" means to define, to document (in writing or electronically) and to implement. Quick Contact: NetZealous DBA as GlobalCompliancePanel Phone: 1-800-447-9407 Fax: 302-288-6884 Email: support@globalcompliancepanel.com
  • 84 Request Info

    Seminar on U.S. Payments Industry: The Players, Trends, and Compliance Issues Faced

    The U.S. payments industry is struggling with an identity crisis. Regulatory authorities are demanding that the payments industry tighten their reins on the adherence to regulations and compliance mandates; technology is enabling payments providers, banks, and networks to venture further into new frontiers; practitioners are worried about security; and infrastructures are getting old and in need of repair or replacement. The task of replacing these systems is so daunting; no wonder no one wants to launch a project to overhaul the enterprise payments network within the business or within the banks. Quick Contact: NetZealous DBA as GlobalCompliancePanel Phone: 1-800-447-9407 Fax: 302-288-6884 Email: support@globalcompliancepanel.com
  • 85 Request Info

    Seminar on Statistics for the Non-Statistician

    Statistical tools and techniques are very commonly used to help measure and improve the quality of a firm's process and product. If statistical analysis is not properly performed and/or understood, a firm can run the risk of distributing the kind of product to the market that ultimately fails, resulting in lost time and money. And of course, with statistics, practice makes perfect. Quick Contact: NetZealous DBA as GlobalCompliancePanel Phone: 1-800-447-9407 Fax: 302-288-6884 Email: support@globalcompliancepanel.com
  • 86 Request Info

    Seminar on Applied Statistics for FDA Process Validation

    In Guidance for Industry Process Validation: General Principle and Practices, process validation is defined as, ""...the collection and evaluation of data, from the process design stage through commercial production.." The guidance further delineates the 'process design stage through commercial production' into three distinct stages of the product lifecycle Quick Contact: NetZealous DBA as GlobalCompliancePanel Phone: 1-800-447-9407 Fax: 302-288-6884 Email: support@globalcompliancepanel.com
  • 87 Request Info

    Seminar on Preparing to Comply with the New FDA FSMA Rules: Planning Valid Preventive Food Safety Controls

    Validation of preventive controls is where the rubber meets the road in terms of prevention. You can develop a food safety plan, implement the plan and verify the plan, but if your data does not prove that you are actually preventing food safety problems, the plan is not considered valid and your overall food safety effort will fail audits. Quick Contact: NetZealous DBA as GlobalCompliancePanel Phone: 1-800-447-9407 Fax: 302-288-6884 Email: support@globalcompliancepanel.com
  • 88 Request Info

    Seminar on Quality by Design - Essential Techniques for Medical Devices

    Design Controls are essential for producing safe and effective medical devices. And Design Controls are considered a critical process by the FDA. Yet, Design Controls are still one of the most frequent areas for 483 and Warning Letter observations. This 2 day seminar will help you understand, develop, and implement design controls processes and tools that are a competitive strength for your company. You will learn how to incorporate design controls into your product development process to help streamline development and ensure quality and compliance. NetZealous DBA as GlobalCompliancePanel Phone: 1-800-447-9407 Fax: 302-288-6884 Email: support@globalcompliancepanel.com
  • 89 Request Info

    Seminar on The Complete Payroll Law

    This course covers a very broad range of topics from worker classification, to employee classification, to establishing methods and rates of pay, what must be included in the rate of pay, hours that must be compensated as worked time, required benefits, de minimus working fringes, withholdings and deductions from pay, voluntary deductions, child support and garnishment orders, payroll reporting, analysis of risks of noncompliance, proper documentation of your policies and procedures and record retention requirements. We will show where to find the laws, how to interpret them and how to apply them in the most effective ways. Quick Contact: NetZealous DBA as GlobalCompliancePanel Phone: 1-800-447-9407 Fax: 302-288-6884 Email: support@globalcompliancepanel.com
  • 90 Request Info

    Seminar on Preparing Premarket Submissions that secures U.S. FDA Clearances/Approvals: 510(k)/Pre-IDE/IDE and PMA

    The U.S. FDA regulatory 510(k) clearance and Premarket Approval (PMA) process is considered a most stringent and complex. Only a good knowledge of U.S. FDA laws, regulations, and requirements is not sufficient to win a clearance/approval. You are required a proper training on how to set and state regulatory arguments for your device in a most convincing manner to the U.S. FDA reviewer Quick Contact: NetZealous DBA as GlobalCompliancePanel Phone: 1-800-447-9407 Fax: 302-288-6884 Email: support@globalcompliancepanel.com
  • 91 Request Info

    Seminar on HIPAA 2017

    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. It will also address major changes under the Omnibus Rule and any other applicable updates for 2017 and beyond. There are an enormous amount of issues and risks for covered entities and business associates these days. Quick Contact: NetZealous DBA as GlobalCompliancePanel Phone: 1-800-447-9407 Fax: 302-288-6884 Email: support@globalcompliancepanel.com
  • 92 Request Info

    HIPAA Compliant Fundraising 2017

    In 2013, The US Department of Health and Human Services made major changes to rules implementing The Health Insurance and Portability Act of 1996 (HIPAA) and Health Information Technology for Economic and Clinical Health Act of 2003 (HITECH). Among the many areas impacted by these rules (billing, marketing, research, IT security, etc.) is fund raising. The amendments significantly modify the methods and practice that hospitals, their institutionally related foundations, and other healthcare charities may or must employ when using ANY patient or client information for fund raising. The webinar will cover how to effectively implement the fund raising regulations in a manner that increases both opportunities for philanthropic support and compliant implementation of the new mandates.
  • 93 Request Info

    Email & SMS Communication of HIPAA Challenges 2017

    Email and text message are subject to the HIPAA Security Rule transmission standard. Changes in the Omnibus Rule in 2013 further clarified the importance of proper usage of email and text message, examples of electronic transmission media. Oftentimes used as a method to transmit PHI, electronic transmission media is an area that covered entities need to develop and implement policies and procedures to ensure HIPAA compliance.
  • 94 Request Info

    HIPAA for Dummies 2017

    This lesson is going to get back to the basics using multiple real life scenarios and "what if's". My goal is to make this very confusing and not well explained law easy to understand for the typical staff member. I will uncover myths versus reality as it relates to this 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. I will also point out multiple court cases I have been affiliated with where a staff member of a hospital or clinic has been sued or even imprisoned!
  • 95 Request Info

    Introduction to Industrial Statistics 2017

    This is an introductory course in industrial statistics that will equip the attendee to understand what he or she needs to know about basic descriptive statistics such as measurements of central tendency (average) and variation (range and standard deviation), and to use graphical methods such as the box and whisker plot to visualize these statistics for data sets. The concepts of variation and accuracy, and their effects on outgoing quality, will be introduced at the beginning. The basic data visualization tools of the histogram and Pareto chart also will be presented. Read More : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900904SEMINAR?channel=mailer&camp=Seminar&AdGroup=trainingregistry_April_2017_SEO
  • 96 Request Info

    Medical Devices Industry and Risk Management 2017

    Gaps, incorrect or incomplete implementation of software can delay or make the certification/approval of medical products impossible. Most activities cannot be retroactively performed since they are closely linked into the development lifecycle. Diligent, complete and correct implementation of risk management from the start of product development is therefore imperative. This course will introduce all necessary steps to design, implement and test critical medical device software in a regulatory compliant environment. Software risk management has to be embedded into the bigger scope of overall risk management. Therefore this course will additionally address the system level risk management and the resulting interfaces to software. Read More : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900888SEMINAR?channel=mailer&camp=Seminar&AdGroup=austinmonthly_April_2017_SEO
  • 97 Request Info

    Seminar on FDA Data Integrity for Computerized Systems in Mumbai

    The Problem: We have all heard of Data Integrity but do you really understand what it is? Do you understand how 21 CFR 11 and Annex 11 fit into this picture? Specifically, can you answer questions on the following? • Evolution of 21 CFR Part 11 and Annex 11 and Why they are Back in the News • Overview and Key Requirements of Part 11 & Annex 11 • How to use a Risk Based Assessment to reduce work while still achieving Data Integrity and Compliance? • How FDA & other Regulatory Authorities Inspect Computerized Systems for Data Integrity? I often refer to 21 CFR 11 and Annex 11 as Good Software Engineering with the Documentation on Steroids! However, unless one knows how to implement Data Integrity, it is often very hard to apply requirements for DATA INTEGRITY to computerized system, and very hard to determine what needs to be done, to meet domestic and / or international regulations or business continuity requirements.
  • 98 Request Info

    Seminar on Product Information for Medicinal Products in the EU 2017

    Regular review and monitoring of product information for medicines is important, to support awareness of relevant updates/changes which may affect prescribing, dispensing, administration or monitoring practices. It is also important that patients and caregivers, as appropriate, are made aware of the information contained in the Package Leaflet (PL) and should be encouraged to read it prior to and during their treatment.
  • 99 Request Info

    Developing Technical Training in the Life Sciences 2017

    Developing Technical Training in the Life Sciences is a 2-day seminar that addresses the unique challenges of developing and managing training in Life Sciences companies. The Life Sciences pose unique challenges to training developers. The first day of this seminar will concentrate on providing foundational knowledge concerning training and development within the Life Sciences. Four 90 minute sessions will be presented on this first day that will guide the participant from a discussion of the role and function of the technical training function to the actual creation of the training organization. Important to this first day, are discussions of performance-based training, the fundamentals of training (jobs, duties, tasks, and steps to include performance objectives) and how human performance and training are inextricably linked. Knowing about human performance and how to apply human performance principles are crucial to designing, developing, and managing an effective technical
  • 100 Request Info

    FDA's GMP Expectations for Phase I and First-in-Man Clinical Trials 2017

    Early clinical trials are conducted to establish initial safety of a drug. The studies are generally in small number of healthy subjects and use lower doses of the drug product. Therefore, only small amounts of investigational material are required. In order to not undertake substantial costs and to reduce regulatory burden during these early stages, the FDA has established guidelines to allow early stage investigational products to be manufactured under less stringent GMPs. Why should you attend: To gain an understanding of the requirements for advancing drugs from research into early clinical development and the minimum FDA requirements for phase I GMPs. To learn practical applications for implementing phase I manufacturing strategies to meet FDA requirements.