FDA and EMA have communicated their expectations for trial oversight/ monitoring, monitoring systems, and investigative site oversight. These are described in the FDA Guidance Oversight of Clinical Investigations: A Risk- Based Approach to Monitoring and the EMA Reflection Paper on risk-based quality management in clinical trials both of which will be reviewed in this web seminar.
This session will provide some insight into current trends in cybersecurity threats to medical devices and how to follow industry best practices to prevent and/or mitigate these threats. Cybersecurity is a serious concern for medical device safety and effectiveness. Without protection, software running on a medical device could cause severe injury or death to a patient.
There are many forms of cybersecurity and many remedies for thwarting attempts to penetrate medical device software. Most of these are based in physical and logical security practices that are becoming best industry practices. This webinar will detail some of the threats and ways to mitigate them to protect consumers from harm.
Join this webinar to understand the power of Power BI analytics and the impact it can have on your business.
Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 firstname.lastname@example.org Event link https://www.onlinecompliancepanel.com/webinar/Power-BI-Using-Data-to-Drive-Results-507898/JULY-2018-ES-TRAININGREGISTRY
This program will cover CMS grievance interpretive guidelines and section 1557 of the Affordable Care Act.
Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 email@example.com Event link https://www.onlinecompliancepanel.com/webinar/Grievances-and-Complaints-Ensuring-Hospitals-Compliance-with-the-CMS-CoPs-Joint-Commission-DNV-Standards-and-OCR-503161/JULY-2018-ES-TRAININGREGISTRY
This presentation reviews the latest research into the human microbiome, relation to the skin and levels of controls and risks required such as behaviors and gowning practices.
Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 firstname.lastname@example.org Event link https://www.onlinecompliancepanel.com/webinar/Human-Microbiome-and-Implications-for-Contamination-Control-503149/JULY-2018-ES-TRAININGREGISTRY
This webinar will notify how US FDA updated its PMA acceptance process and refuse to accept policy for initial reviews of (k) submissions.
Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 email@example.com Event link https://www.onlinecompliancepanel.com/webinar/Understanding-the-FDA-s-Revised-Medical-Device-Product-Guidance-Refuse-to-Accept-Policy-for-510-k-s-and-Acceptance-and-Filing-Reviews-for-Premarket-Approval-Applications-PMAs-503623/JULY-2018-ES-TRAININGREGISTRY
Join this webinar to understand how Risk Management applies throughout the product life cycle and links to design control, production and process controls, and CAPA.
Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 firstname.lastname@example.org Event link https://www.onlinecompliancepanel.com/webinar/Risk-Management-Techniques-for-Medical-Devices-506211/JULY-2018-ES-TRAININGREGISTRY
Attend this webinar to gain an understanding of FDA and ISO 13485 requirements for process validation and how to implement them.
Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 email@example.com Event link https://www.onlinecompliancepanel.com/webinar/Process-Validation-Overview-of-Why-and-How-507096/JULY-2018-ES-TRAININGREGISTRY
Learn how to document the medical records to support medical necessity and how to avoid common errors that invariably trigger medical record audits.
Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 firstname.lastname@example.org Event link https://www.onlinecompliancepanel.com/webinar/Is-my-Documentation-meeting-Medical-Necessity-509484/JULY-2018-ES-TRAININGREGISTRY
Upon completing this course participants should be able to:
Evaluate linear quantitative measurement procedures and sources of error.
Distinguish the difference between confidence and tolerance intervals
Evaluate the appropriateness of the effect of sample size in given procedures.
Evaluate laboratory/clinical quality control based on risk management
Interpret statistical process control
Distinguish between FDA requirements and ICH guidelines
Europe's new Medical Devices Regulation 2017/745 (MDR) takes effect in May-2020. That seems like plenty of time, but smart companies should start planning their CE transition strategy right away. With manufacturers all over the world transitioning to the MDR and ISO 13485:2016 in the next few years, Notified Body staff shortages and work backlogs are likely to cause delays.
This two-day seminar will provide you insights that allow you to identify the best transition strategy for your company based on your product range, certification cycle, markets you serve, and your Notified Body.
This course will begin by presenting a primer on statistical analysis, focusing on the methods required for analysis of designed experiments. It will then present the steps to DOE, while demonstrating valuable risk management tools (Ishikawa and FMEA) which can be use pre and post DOE studies. Next, participants will learn to generate and analyze multiple screening and response surface designs; the participants will leave with an understanding of why and how each are used. Then, the participants will learn how results of the studies can be presented. Lastly, using the results of the studies, the risk management tools will then be updated.
This presentation, will aid manufacturers of medical devices who intend to modify a 510(k)-cleared device or a preamendments device subject to 510(k) (i.e., "existing devices") during the process of deciding whether the modification exceeds the regulatory threshold of 21 CFR 807.81(a)(3) for submission and clearance of a new 510(k).
This Project management training will provide you with a solid foundation for managing that first project or to simply sharpen existing project management skills, It is not just important to learn about project management - project management has its own body of knowledge, Also The webinar is designed to build a working understanding of the subject and for a quick start-up for those unanticipated project management assignments.
Attend this webinar to learn how to reduce the risk of penalties in your practice and tips for avoiding breaches and learn about real-life HIPAA compliance issues.
Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 email@example.com Event link https://www.onlinecompliancepanel.com/webinar/Is-Your-Medical-Practice-HIPAA-Compliant-Requirements-for-Privacy-Security-and-Breach-Notification-508689/JUNE-2018-ES-TRAININGREGISTRY
Review of basic polymer chemistry and changes in polymer characteristics can be anticipated and designed for. Learn how to plan for post radiation resistance and lifetime functionality. All radiation modalities (gamma, e-beam, x-ray) will be reviewed for a basic understanding of the sterilization process and the influences that product design and assembly can have on success.
This webinar can help you understand your responsibilities in terms of Purchasing Controls enabling you to provide safe and effective products to your customers. Learn how to prevent quality and compliance problems by having a strong system for Purchasing Controls!This webinar will help you to understand the regulations and how you can translate them into an efficient and effective process for purchasing/ supplier control.
You'll learn about the essential elements of purchasing control and how you can translate them into your procedures. We'll discuss the process steps for purchasing control and how it relates to other parts of your QMS including receiving and acceptance activities.
This webinar focuses on DOE strategies, and explains use of DOEs during process validation, The effective and progressive use of a Screening DOE, a Mapping DOE and a Robust Process DOE will lead to a better understanding of the process and the location of the best optimum.
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.
During this introductory session, delegates will gain a complete guide to the status and impact of the latest guidelines for combination products. Examples (company specific) of combination products will also be discussed to gain insights into their variety and complexities.