Yuval Shapiro is the founder of QWV – Quality with Value, QA/RA Services. An expert for products and companies primarily related to medical devices that meet the real needs of their clientele. Substantial experience gained in various multi-discipline technology industries (Military, Telecom & Medical Devices), and give a high-value contribution to quality and reliability projects related to the medical device and telecom industries. More than 20 years of experience in QA; including MD&D RA & QA;QMS (21CFR - Part820, ISO13485, TL9000, CMDCAS, ISO9001). EH&S Systems; QA/RA representative in R&D Projects; Risk Analysis as per ISO14791& ISO31000; EMC & Safety Certifications.
June 12 2023
01 : 00 PM EST
Basics of Production Process Validation
The presentation shall cover the following aspects of production process validation:What is Production Process Validation?Why is it Required? When is a production process validation required? Regulatory Sources (Europe - ISO13485: 2016, US/FDA – 21CFR820, IMDRF) The Process of Validation: IQ - Installation Qualification, OQ – Operation Qualification, PQ – Performance QualificationWhat should be done f..
July 10 2023
01 : 00 PM EST
Sampling plans for Verification, Validation and Production
This presentation shall describe how to create Sampling Plans for verification and validation, production process validation and production control. The webinar will include the theoretical background of sampling, several examples and formulas for easy construction of sampling plans.Areas CoveredBasic StatisticsThe main parameters that should be considered Formulas related to SamplingSampling Standard..
Cost of Quality for Medical Devices
How can one assess the effectiveness of a Quality Management System?The best way to do that is by using the ultimate transfer unit: MONEY!The purpose of a firm is to make Money, the purpose of a QMS is to enable the firm to produce, and therefore – generate money with minimum losses that are reflected by failures.The principles are known, but is it done?This lecture will give the listener the basic know-how..
EU Medical Devices Regulation: The Practice
The EU Medical Device Regulation (MDR 745/2017) represents a considerable change from the directives it is replacing. Device manufacturers who conduct business in the EU must start their transition now in order to meet the deadline. This training is the first peek into this uncharted realm. During this class, participants will be introduced to the new requirements in the Medical Device Regulation (MDR), inc..
New ISO14971: 2019 Risk Management Standard for Medical Devices – Implementation
Mr. Shapiro shall present the basic principles and practices of Risk Management and Risk Analysis. The risk-based approach has become a key element of quality management and as a fundamental process in the design and development of medical device products. This process has been streamlined within ISO14971 standard and has become the best practice to show the application of risk-based approach implementation..
Sample Size Selection: Is That Number Right?
Mr. Yuval Shapiro shall review the basic statistics that are behind the Sample Size selection. Explanations on how to select samples for the Design (verification and validation) phase, and for the Production phase. Also, explanations on how to use the ISO2859-1 for simple cases at production shall be provided. Selection of the correct sample size is a challenging task, especially, when regulatory authorit..
The New EU-Medical Devices Regulation (745/2017)
The EU Medical Device Regulation (MDR 745/2017) represents a considerable change from the directives it is replacing. Device manufacturers who conduct business in the EU must start their transition now in order to meet the deadline. This training is the first peek into this uncharted realm. During this class, participants will be introduced to the new requirements in the Medical Device Regulation (M..