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.
Course "Clinical Evaluation Report for Europe and MEDDEV Expectations: Impact with New Medical Device Regulations (MDR)" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
Clinical Evaluation Report and MEDDEV
Consulting Case Study Practice
Case Study Practice
Interactive Exercises and Discussions
Questions and Summary
Venue: Hilton Zurich Airport, Zurich, Switzerland
The webinar includes a brief overview of the Interagency Appraisal and Evaluation Guidelines and its requirements for appraisal reviewers and what agencies enforce USPAP.
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/USPAP-Issues-Best-Practices-for-Residential-Appraisal-Reviewers-Avoiding-Violations-508477/JULY-2018-ES-TRAININGREGISTRY
Learn best practices to protect accounts payable payment process from potential fraud and risk management techniques for handling ACH, Check, and Credit Card Fraud.
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/Accounts-Payable-Payment-Fraud-Risk-and-Risk-Mitigation-ACH-Check-and-Card-505141/JULY-2018-ES-TRAININGREGISTRY
Join this webinar to understand relevant inspection steps in relation to Root Cause, how to use RCA to better effect, what RCA tools really, more.
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/Problem-Solving-Root-Cause-Analysis-in-Pharma-Manufacturing-503456/JULY-2018-ES-TRAININGREGISTRY
This webinar will discuss the best practices of analytical method validation, including components of a validation, how to include critical reagents comparison, selectivity experiments, assessment of stability, importance of communication between the development and the validation labs and accuracy of transfer documents.
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 firstname.lastname@example.org 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 webinar will explain the implementation of ISO 62366 and the regulatory expectations discussed in the 2016 FDA Guidance for a compliant human factors/ usability program.
The ISO 62366 is an "Consensus"Standard, making it a gold standard for regulatory submissions. We will look at other reference points regarding HF, like AAMI/ANSI HE75:2009 and how HF Engineering include consideration of:
Use Environments and User Interfaces
Exploratory HF/Usability Evaluations
Hazard Mitigation and Control
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.
This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow. It will begin with a strategic view of SOPs in a company and how SOPs can help streamline operations in addition to ensuring regulatory compliance.
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.
There are many questions about the ongoing inspection and enforcement program, e.g., what inspectors are looking at, what are major findings and what are the FDA expectations about follow up.
The seminar will have the answers. And using industry proven case studies on how to avoid 483 inspectional observations and warning letters attendees will learn how to prepare their organization for trouble-free Part 11 related inspections.
This webinar will be focused on processes and approaches to increase fiscal return and mitigate fiscal compliance risk for clinical trials. The ability to develop robust budgets, ensure billing compliance and adherence to CMS-Medicare regulations for clinical trials remains a challenge for many clinical sites, sponsors and Contract Research Organizations (CROs).
Submission of pharmacogenomics data as part of a drug or biologic submission, impacts the approval of the submitted product. Complying with FDA requirements on the subject will help with approval of the submitted product. In addition, regulations are coming into place, for the re-imbursement of the genomic tests.