Public Education

Who cares for the care provider? Both paid and non-paid persons who offer their compassion, skills and resources to those in need are often at risk for burnout, compassion fatigue or vicarious traumatization, creating costly health and emotional challenges and also gaps in expertise and caring. Care providers must be reminded how to assert themselves, set healthy boundaries and respond to stress in healthy ways. Focus groups held by HCEI across the US confirm the need to celebrate the spirit and journey of caring persons while teaching self-preservation skills for the future. When caring persons care for themselves they provide better care for others. Seminar participants will be able to: Understand dynamics of providing care Articulate how each person experiences stress uniquely Identify symptoms of compassion fatigue Utilize practical, proven solutions and exercises for stress reduction Set healthy goals and create a future response plan for stress.

This session is designed to provide intensive, two-day training in HIPAA compliance, including what's new in the regulations, what's changed recently, and what needs to be addressed for compliance by covered entities and business associates. The session provides the background and details for any manager of healthcare information privacy and security to know what are the most important privacy and security issues, what needs to be done for HIPAA compliance, and what can happen when compliance is not adequate. Audits and enforcement will be explained, as well as privacy and security breaches and how to prevent them. Numerous references and sample documents will be provided. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901357SEMINAR?trainingregistry-November-2017-SEO

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. 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? Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901312SEMINAR?trainingregistry-November-2017-SEO

If you go "off label" with advertising and promotion, FDA's hammer can hit hard and seemingly out of the blue. Advertising and promotion for devices is weak and lacks legal clarity. For drugs, the regulations are prescriptive and guidance documents clamp down on nuances. Marketing and regulatory affairs departments must collaborate to avoid the hammer and penalties of FDA. The roadblock, however is that marketing managers and regulatory affairs managers rarely reach common ground and are loathe to even consult with each other. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901102SEMINAR?trainingregistry-November-2017-SEO

Auditing analytical laboratories can be complex because of the preparation that is often required. All of the GMP rules do not apply to the laboratory; while there may be additional requirements depending upon the type of testing that is being conducted. In many cases, the laboratory itself may not understand what regulations apply to the work that is being conducted. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901324SEMINAR?trainingregistry-November-2017-SEO

Testing is the science of identifying defects, so that they can be corrected, and of demonstrating that a system meets intended requirements. Testing computerized systems is considered a fundamental verification activity and appropriate testing is a regulatory expectation as described in many regulations e.g. EU GMP Annex 11. "Evidence of appropriate testing methods and test scenarios should be demonstrated. Particularly system (process) parameter limits, data limits and error handling should be considered" The regulated company is responsible for demonstrating compliance and fitness for use. Effective testing demonstrates compliance with regulatory requirements and ensures patient safety, product quality and data integrity as a result of controlling identified risks. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901360SEMINAR?trainingregistry-November-2017-SEO

Being in compliance with HIPAA involves not only ensuring that you provide the appropriate patient rights and controls on your uses and disclosures of Protected Health Information; but that you also have the proper policies and procedures in place. If audited or the subject of a compliance review, you will be required to show the government you have all the necessary documentation in place for safeguarding patient Protected Health Information and indicate how you addressed all required security safeguards. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901282SEMINAR?trainingregistry-November-2017-SEO

This 2-day seminar will cover the essentials of compliance for medical device companies. An efficient and effective quality system can be a competitive advantage for companies by leading to improved quality and compliance as well as optimizing the cost of quality. This "Compliance Boot Camp" will get you started in setting up just such a Quality System. We'll discuss the "case for quality" and how you can use compliance, not as an end itself, but as a means to improved quality and reduced cost of non-compliance. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901152SEMINAR?trainingregistry-November-2017-SEO

The final version of ISO 13485:2016 is now available and companies should be planning their implementation. There are significant changes from the earlier version; they will require major modifications to the Quality Management System (QMS). The new version has better alignment with FDA's QSR, but there are still major differences that create issues for effective QMS implementation. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901112SEMINAR?trainingregistry-November-2017-SEO

This course will present the procedures that must be used in the application of DOE and SPC to the development, design and monitoring of manufacturing and testing processes. A practical approach with case studies and examples will be used, with theoretical information introduced only when necessary to understand an experiment. Examples from real processes and testing procedures will be used to present the student with examples that will be directly applicable to their work. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901327SEMINAR?trainingregistry-November-2017-SEO

This course will present, in one place, the regulations and guidelines that apply to early phase products. In some cases these will not be regulations, but needs that, if met, will increase the efficiency of activities as a product proceeds through the development process. The course will present these items in the order of product development from the point of R & D activities to the completion of Phase 2 clinical trials. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901321SEMINAR?trainingregistry-November-2017-SEO

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. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901162SEMINAR?trainingregistry-November-2017-SEO

Complaint handling is likely one of the more cross-functional parts of your quality system: Customer Service may receive your customer complaints, Sales and Marketing may need to reach out to the customer for additional information, Regulatory Affairs may determine whether the complaint is reportable, QA may perform the root cause investigation, R&D or Manufacturing Engineering may need to be involved in the corrective action, and Quality Engineering may need to trend the complaints! Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901336SEMINAR?trainingregistry-November-2017-SEO

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. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901297SEMINAR?trainingregistry-November-2017-SEO

An essential task in any compliance analytics workflow is to not only explore your data visually, but also to communicate your results professionally with graphic displays. Do you have the tools and skills to quickly and thoroughly perform these tasks? This course in data visualization will present methods to allow you to interactively discover relationships graphically. We will provide the foundations for creating better graphical information to accelerate the insight discovery process and enhance the understandability Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901116SEMINAR?trainingregistry-November-2017-SEO

This two-day seminar will begin by laying the foundation for the subject by first defining what a project is and then discussing the unique roles that the project manager must assume along the length of any project. The Triple Constraint, the most fundamental of project management principles, will be explained in detail with examples and tools provided that can be used to integrate the principle into any project management process. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900998SEMINAR?trainingregistry-November-2017-SEO

This course will present, in one place, the regulations and guidelines that apply to early phase products. In some cases these will not be regulations, but needs that, if met, will increase the efficiency of activities as a product proceeds through the development process. The course will present these items in the order of product development from the point of R & D activities to the completion of Phase 2 clinical trials. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901318SEMINAR?trainingregistry-November-2017-SEO

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. Statistics of course, requires constant practice. This seminar will be highly interactive and participative. Participants apply their learning of statistics to real-world example data sets. The program begins by providing a basic overview of the most common statistical tools and terms. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900982SEMINAR?trainingregistry-November-2017-SEO

Classification systems differ from that of the United States or European Union in select countries Medical devices are classified depending on their risk level Medical devices must also comply with additional country standards and these standards define industry-wide safety and performance requirements Regulatory registration process is defined for China, Hong Kong, India, Japan, South Korea, Taiwan, Singapore and Australia Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900992SEMINAR?trainingregistry-November-2017-SEO

Engineers are dedicated to making things work, so a focus on how they might fail and harm someone can seem alien. Managing risk, however, is essential for all medical products- medical devices, including those involving software, have produced some painful examples of poor risk management with serious consequences. Experience has shown that there is a better way, that it is possible to manage risk in a changing business and technical world. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901342SEMINAR?trainingregistry-November-2017-SEO