14971 Web-based Seminars

Proper Documentation of Risk Management for Compliance with ISO 14971 - Webinar GlobalCompliancePanel Overview: There are a wide variety of risk management tools cited in ISO 14971, the medical device risk management standard. Tuesday, May 8, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Post-Design Medical Device Risk Management - Webinar GlobalCompliancePanel Overview: In this presentation we will explore the requirements for post-design risk management and determine how to apply the requirements. Tuesday, April 24, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Proper Documentation of Risk Management for Compliance with ISO 14971 - Webinar By GlobalCompliancePanel There are a wide variety of risk management tools cited in ISO 14971, the medical device risk management standard. Tuesday, May 8, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Post-Design Medical Device Risk Management - Webinar By GlobalCompliancePanel In this presentation we will explore the requirements for post-design risk management and determine how to apply the requirements. Tuesday, April 24, 2012 10: 00 AM PST | 01: 00 PM EST  more...

ISO 13485 as a Quality Management System for Medical Devices - Webinar GlobalCompliancePanel This presentation will help you to understand ISO 13485 and implement a successful quality management system, comparing it to ISO 9001 and FDA & European Union requirements. Thursday, February 16, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Master Verification Validation Planning under US FDA CGMP ICH Q-series and ISO 13485-14971 Requirements - Webinar By GlobalCom FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. Wednesday, March 21, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Risk Management in IEC 60601-1 Third Edition - Webinar By GlobalCompliancePanel ...f the new standard. Areas Covered in the Session: ISO 14971 compliance is a requirement of IEC 60601-1 The new standard uses risk management throughout The new standard is less prescriptive in many areas The new standard requires that all applicable collateral and particular standards must be used for compliance Current activities leading to full implementation of the standard  more...

Use and Mis-use of FMEA in Medical Device Risk Management - Webinar By GlobalCompliancePanel This webinar will update personnel at medical device companies on the ISO 14971 standard and point them to the additional information available in the document under the informative annexes. The information will assist in meeting various national and global regulatory requirements for medical devices.  more...

A Simpler Approach to Implementing or Validating CGMPs to 21 CFR 11 Electronic Records Signatures - Webinar By GlobalComplianceP ...industry software validation models, coupled with the ISO 14971 / ICH Q9 Product Risk Management models, to structure, run, and document acceptable cGMP Part 11 software validations. The FDA and other regulatory agencies have stated that software validation can realistically only be accomplished effectively if "risk-based". How can this be accomplished in the "real world". This webinar will  more...

Develop and Execute the Company Software VV Program - Webinar By GlobalCompliancePanel ...industry software validation models, coupled with the ISO 14971 / ICH Q9 Product Risk Management models, to structure, run, and document acceptable software validations. The FDA and other regulatory agencies have stated that software validation can realistically only be accomplished effectively if "risk-based". How can this be accomplished in the "real world". This webinar will address software  more...

Root Cause Analysis - The Heart of a Successful CAPA Program - Webinar By GlobalCompliancePanel ...egulatory agencies world wide, with good reason. EU's ISO 14971 (Device Risk Management) and the FDA's QSIT and Q9, underscore this increased emphasis. A valid closed-loop CAPA system requires root cause analysis for true problem (not symptom) resolution. Growing high-profile field problems indicate that effective root cause analysis is still not the industry norm. The billions of dollars  more...

Developing the Master VV Plan to Meet US FDA ISO 13485 and 14971 Requirements - Webinar By GlobalCompliancePanel ...ster Validation Plan, evaluating its elements against ISO 14971 hazard analysis / risk management, allows development of meaningful product validations. The roles of different V&V protocols. How to employ equipment / process DQs, IQs, OQs, and PQs, or their equivalents, against a background of limited company resources (personnel, budget, time). A matrix simplifies "as-product", "in-product",  more...

FMEA and Risk Management for Medical Devices - Webinar By GlobalCompliancePanel ...s terms used in risk management and the importance of ISO 14971 & ISO 13485 in the managements of risks during the life cycle of medical devices starting with design and manufacture. FMEA (Failure Mode & Effects Analysis) is only a segment of Risk Management, but quite valuable for assessing Risk as part of Risk Management. Now that EN 1441 Risk Analysis is obsolete & upgraded to 14971  more...

Understanding ISO 13485 vs ISO 9001 for Successful QMS in Medical Device Industries - Webinar By GlobalCompliancePanel Overview: ISO 13485: 2003 is a quality management system standard specially written for the medical device industry and is on the U S Food & Drug Administration (FDA) list of recognized consensus standards. Medical device firms certified to ISO 13485: 2003 will find themselves very closely compliant with FDA's Quality System Requirements under 21CFR 820. This presentation will help you to  more...

Overall Residual Risk Evaluation - Webinar By GlobalCompliancePanel ...is activity, and although some information appears in ISO 14971, there is not sufficient guidance on how to perform Overall Residual Risk Evaluation. Areas Covered in the Session: * Choosing the Evaluation Team * Determining the Evaluation Process * What documents should be part of the review? * Using the Risk Chart in the review * How to compare to the Risk  more...

Documentation for IEC 60601-1 3rd Edition Compliance - Webinar By GlobalCompliancePanel Overview: In this presentation we will review the certification requirements for documentation of the clauses of IEC 60601-1 Third Edition. The purpose will be to provide medical device manufacturers with information on how to provide certification bodies with the information they need to certify products to the Third Edition in the most efficient manner. By preparing in advance for  more...

Developing the Risk Management Plan - Webinar By GlobalCompliancePanel ...ements of the medical device risk management standard ISO 14971 is to develop a Risk Management Plan. One of the least understood and executed requirements are the Risk Management Plan. As ISO 14971 becomes required for product safety certification and is audited by regulators this requirement will become a greater issue. The Risk Management Plan establishes the risk management activities  more...

Developing and Using the Product Risk Management FileReport - Webinar By GlobalCompliancePanel ...actical and given the 'state of the art' at the time. ISO 14971 and ICH Q9 provide accepted methodologies by which to perform and document such an analysis and is accepted by the FDA. These activities can also be used as a method to train new hires, especially in Marketing, QA/ RA, Engineering, and Manufacturing. This webinar will address the procedures, provide and discuss suggested templates,  more...

Validating Excel and Word Applications Documents - Webinar By GlobalCompliancePanel ...e? How can these consistently be executed? Where does ISO 14971, ICH Q9, and similar risk management systems come in? This webinar will evaluate the climate that has resulted in this call for change, and flag areas for heightened compliance in V&V planning. It will focus on eliminating major systemic validation problems. It will assist the attendee to review their existing system in light of  more...

Master Verification and Validation Planning to Meet US FDA ISO 13485 and 149712009 Requirements - Webinar by GlobalCompliancePan ...ster Validation Plan, evaluating its elements against ISO 14971 hazard analysis / risk management, allows development of meaningful product validations. The roles of different V&V protocols. How to employ equipment / process DQs, IQs, OQs, and PQs, against a background of limited company resources (personnel, budget, time). A matrix simplifies "as-product", "in-product", process, and equipment,  more...

Statistical Concepts of Process Validation - Webinar by GlobalCompliancePanel The FDA QSR requires device manufacturers to validate processes when the manufacturer cannot "fully verify the output". The manufacturer must validate these processes with a "high degree of assurance". The presentation explores the statistical underpinnings of these two phrases. To "fully verify the output" relates to the use of statistical sampling plans, while "high degree of precision"  more...

Proper Use of Risk Management Tools for ISO 14971 Medical Device Safety - Webinar by GlobalCompliancePanel In this presentation we will use examples of the use of the tools for medical device risk management to complete the risk management process for a sample medical device. During the presentation we will refer to the risk management standard ISO 14971 and its requirements. We will give examples for completing the documentation requirements of the standard. The presentation is intended to give  more...