ISO Medical Device Industry

This session will help you understand how to use design control in the production of Medical devices while ensuring the quality and compliance. Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link - https://www.onlinecompliancepanel.com/webinar/Quality-by-Design-Essential-Techniques-for-Medical-Devices-509040/MARCH-2019-ES-TRAININGREGISTRY

Learn how to create Design History Files, Device Master Records and Design History Files using lean document and lean configuration methods. Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link - https://www.onlinecompliancepanel.com/webinar/Design-History-File-DHF-the-Device-Master-Record-DMR-and-the-Device-History-Record-DHR-Principles-of-Lean-Documents-and-Lean-Configuration-505849/FEBRUARY-2019-ES-TRAININGREGISTRY

This webinar will review the Medical Device Classification Procedures which includes the De Novo process in conjunction with the recent changes to 21 CFR 860 that pertain to the reclassification of the post amendment devices and the De Novo process in general. Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link - https://www.onlinecompliancepanel.com/webinar/Classifying-Medical-Devices-The-De-Novo-Process-and-the-FDA-s-Final-Rule-to-Simplify-Medical-Device-Classification-Procedures-506011/FEBRUARY-2019-ES-TRAININGREGISTRY

Validation is an important element of the Quality System Regulations and ISO 13485. This course will cover what processes needed to be validated and what steps you need to take to validate processes. You'll also learn the essentials of validation planning, protocol writing, and change management. Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link - https://www.onlinecompliancepanel.com/webinar/IQ-OQ-PQ-in-the-Verification-and-Validation-Process-503996/FEBRUARY-2019-ES-TRAININGREGISTRY

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. This workshop covers the differences from the 2003 version to the 2016 version and offers practical implementation advice to update your QMS. Participants will also learn the differences with QSR and understand how to resolve them. The workshop uses extensive examples and exercises to help clarify the concerns. Click to Continue Reading: https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901429SEMINAR?trainingregistry-April-2018-SEO

What do you do next after you have found a non-conformance? Trying to do an uninformed 'fix' could do more harm than good, if we fix the wrong thing. All we'll do is damage the credibility of our corrective action processes and create doubts about our abilities to fix the weaknesses in our Management System. By using the Ishikawa Fishbone diagram we can take a structured approach to getting to the root of the problem. Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/Preparing-a-Proactive-Root-Cause-Analysis-with-the-Ishikawa-Fishbone-Tool-508166/JANUARY-2018-ES-TRAININGREGISTRY

This webinar will review in detail the FDA QSR and ISO requirements for supplier evaluation and assessment, and discuss cost effective options for many of the common practices for achieving compliance. Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/BEST-PRACTICES-FOR-LEAN-SUPPLIER-MANAGEMENT-IN-COMPLIANCE-WITH-FDA-AND-ISO-13485-REQUIREMENTS-505073/NOVEMBER-2017-ES-TRAININGREGISTRY

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 Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901052SEMINAR?trainingregistry-December-2017-SEO

Validation is an important element of the Quality System Regulations and ISO13485. This course will cover the essentials of validation. You’ll learn about what processes needed to be validated and what steps you need to take to validate processes. You’ll learn the essentials of validation planning, protocol writing, and change management. We’ll cover the steps of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) including tips and best practices. We’ll discuss the top mistakes that companies make and how you can avoid them..Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/TOP-PROCESS-VALIDATION-MISTAKES-509627/AUGUST-2017-ES-TRAININGREGISTRY

With mobile platforms more user friendly, and with computers, tablets and smart phones becoming more powerful, we see an increase in the offering of apps. Some of these apps are specifically targeted to assist individuals in the management of their health and wellness, while other apps are targeted to healthcare providers as tools to assist in the delivery of care.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/MOBILE-MEDICAL-APPS-CYBERSECURITY-509085/AUGUST-2017-ES-TRAININGREGISTRY

This course is a comprehensive review of the changes made to ISO/IEC 17025 during its recent revision. In this course, you will be guided through the impact to your existing ISO/IEC 17025 compliant system, as well as the necessary steps to ensure compliance to the new standard.Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/ISO-IEC-17025-2017-UPDATE-LABORATORY-COMPETENCE-507671/JUNE-2017-ES-TRAININGREGISTRY

Year after year, CAPA is the subsystem cited most frequently during FDA inspections. A robust Corrective and Preventive Action (CAPA) program is of the utmost importance to a medical device manufacturer. A system that identifies and eliminates non-conformances and potential non-conformances enables both regulatory compliance and cost savings. This session will discuss the importance, requirements, and elements of a CAPA program, as well as describing the uses of CAPA data. Application of risk management to your CAPA program will be discussed throughout the webinar.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://www.onlinecompliancepanel.com/webinar/CAPA-PROGRAM-CAPA-DATA-505212/MAY-2017-ES-TRAININGREGISTRY

This webinar will help you have an understanding of Test Method Validations to verify the performance of a Medical Device, global reference standards, the FDA requirements and how to perform successful TMV to ensure your inspection of verification is effective, using detailed real-life case studies.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://onlinecompliancepanel.com/webinar/TEST-METHOD-MEDICAL-DEVICE-508490/MAY-2017-ES-TRAININGREGISTRY

Learn how to respond to subpoenas and investigations while complying with HIPAA requirements, state law regulations and patients' privacy rights.Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://onlinecompliancepanel.com/webinar/MEDICAL-RECORDS-506966/APRIL-2017-ES-TRAININGREGISTRY

Design controls involve the translation of user requirements (aka Voice of the Customer) into specific technical requirements as design inputs. These design inputs then form the basis of the design specification, which becomes the design output. Since design controls requires tracing backwards and forwards in order to link the requirements to their satisfaction, a problem faced by many companies is in having to maintain duplicate information across many controlled documents.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://onlinecompliancepanel.com/webinar/DESIGN-INPUTS-OUTPUTS-TRACEABILITY-MATRIX-504902/MARCH-2017-ES-TRAININGREGISTRY

Everyone knows we must focus on safety in healthcare delivery. Attending this session will help you better understand how the built environment impacts safety and is integrated with operational efficiencies.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://onlinecompliancepanel.com/webinar/LEAN-HEALTHCARE-FACILITY-DESIGN-501911/DECEMBER-2016-ES-TRAININGREGISTRY

This webinar will provide an overview of environmental monitoring and provide aspects of contamination control. Environmental monitoring is the method by which clean rooms are known to maintain a certain level of cleanliness. The methods by which clean rooms are monitored are through viable and non-viable testing.Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://onlinecompliancepanel.com/webinar/ENVIRONMENTAL-MONITORING-PROGRAM-501909/DECEMBER-2016-ES-TRAININGREGISTRY

The Centers for Medicare & Medicaid Services (CMS), in collaboration with public and private partners, is transforming how they conduct business and operations, connect providers and empower consumers and their beneficiaries.CMS enhances its partnerships in a delivery system where providers are supported in achieving better outcomes in health and health care at lower cost for the beneficiaries and communities they serve.Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://onlinecompliancepanel.com/webinar/CMS-QUALITY-INDICATOR-501905/DECEMBER-2016-ES-TRAININGREGISTRY

All life science businesses are required to maintain their Quality Management System (QMS) processes in a state of control, via controlled documents and objective evidence in the form of records. Medical device manufacturing plants, required to follow 21 CFR Part 820, have the additional responsibility to ensure that each and every step of the manufacturing process is controlled by work instructions, SOPs, set-up instructions, equipment maintenance, and support functions, and that evidence of this work is maintained by controlled records.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://onlinecompliancepanel.com/webinar/21-CFR-PART-820-QUALITY-SYSTEM-501907/DECEMBER-2016-ES-TRAININGREGISTRY

Quality Management Systems that Comply with ISO13485:2016" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.Price:$1400.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://www.onlinecompliancepanel.com/workshop/Quality-Management-Systems-that-Comply-with-ISO13485-2016-800016/NOVEMBER-2016-ES-TRAININGREGISTRY