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Instructor : Yuval Shapiro
Product Id : 50024

Overview: Mr. Shapiro shall present the basic principles and practices of Risk Management Approach and Risk Analysis.

Mr. Shapiro shall present the basic principles and practices of Risk Management Approach and Risk Analysis. Presentation best practice tools to manage risk analysis and risk management.

Present some common errors when dealing with risk management.

Present the new additions and changes of the new standard.

Yuval Shapiro is the founder of QWV - Quality with Value, QA or 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 and D RA and QA; QMS (21CFR - Part820, ISO13485, TL9000, CMDCAS, ISO9001). More than 20 years of experience in QA; including MD&D RA & QA; QMS (21CFR - Part820, ISO13485, TL9000, CMDCAS, ISO9001). EH and S Systems; QA or RA representative in R and D Projects. Risk Analysis as per ISO14791 & ISO31000. EMC & Safety Certifications.
Instructor : Yuval Shapiro
Product Id : 50024

Overview: This webinar presents to the participants the new requirements of the standard and how they correlate with the regulatory changes in the EU.

This webinar presents to the participants the new requirements of the standard and how they correlate with the regulatory changes in the EU.

Prior to engaging the process of establishing and certifying a QMS for medical devices or enhancing the QMS to the newly introduced requirements, a review of those requirements and how to approach them is important.

The webinar will present the evolution of the ISO13485 since its initial publication on 1988.

Also, the webinar will exhibit the last evolvement: Risk Approach and Regulatory Requirements Addressing.

In addition, timetables and several tips how to address the certification process will be introduced.

Yuval Shapiro is the founder of QWV - Quality with Value, QA or 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 and D RA and QA; QMS (21CFR - Part820, ISO13485, TL9000, CMDCAS, ISO9001). More than 20 years of experience in QA; including MD&D RA & QA; QMS (21CFR - Part820, ISO13485, TL9000, CMDCAS, ISO9001). EH and S Systems; QA or RA representative in R and D Projects. Risk Analysis as per ISO14791 & ISO31000. EMC & Safety Certifications.
Instructor : Susanne Manz 
Product Id : 50024

Overview: This 90 minute Webinar will cover the concepts of measurement, analysis, and improvement to ensure conformity of products, conformity of the management system, and on-going effectiveness.

This 90 minute Webinar will cover the concepts of measurement, analysis, and improvement to ensure conformity of products, conformity of the management system, and on-going effectiveness.

This webinar includes strategies to improve the efficiency of your Quality Management System (QMS) for medical device companies. An effective yet efficient quality system can be a competitive advantage for companies by leading to improved quality and compliance as well as optimizing the cost of quality.

 This webinar will get you started in setting up just such a Quality System.  We'll discuss techniques for improving efficiency, reducing burden, and still maintain an effective QMS.

In this webinar, we will discuss:

  • Regulatory Expectations
  • Common problems and lessons from 483 and warning letters
  • Red-flags that your QS is not effective
  • Measurement and metrics
  • Feedback, Complaint Handling, Internal Audit
  • Analysis of data
  • Risk based thinking
  • Improvement and your CAPA process
  • Management Review
Susanne Manz ,MBA, MBB, RAC, CQA is an accomplished leader in the medical device industry with emphasis on quality, compliance, and six sigma. She has an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities. While at GE, J&J, and Medtronic, Susanne worked in various world-wide roles including Executive Business Consultant, WW Director of Quality Engineering and, Design Quality, and Director of Corporate Compliance. Susanne has a BS in Biomedical Engineering and an MBA from the University of NM.

She earned her Black Belt and Master Black Belt certifications while at Johnson and Johnson. Susanne also holds Regulatory Affairs Certification (RAC) from RAPS and Certified Quality Auditor (CQA) certification from the American Society for Quality. Susanne has now established a consulting business with a mission to provide services to help medical device companies achieve world-class quality and compliance.
Instructor : Susanne Manz 
Product Id : 50024

Overview: Production and Process Controls (P&PC) are one of the key capabilities necessary for medical device companies. Production and Process Controls (P&PC) are one of the key capabilities necessary for medical device companies to consistently and effectively produce safe and effective products. Because Production and Process Controls are so critical, they are one of the major subsystems emphasized in inspections by the FDA.
Susanne Manz ,MBA, MBB, RAC, CQA is an accomplished leader in the medical device industry with emphasis on quality, compliance, and six sigma. She has an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities. While at GE, J&J, and Medtronic, Susanne worked in various world-wide roles including Executive Business Consultant, WW Director of Quality Engineering and, Design Quality, and Director of Corporate Compliance. Susanne has a BS in Biomedical Engineering and an MBA from the University of NM.

She earned her Black Belt and Master Black Belt certifications while at Johnson and Johnson. Susanne also holds Regulatory Affairs Certification (RAC) from RAPS and Certified Quality Auditor (CQA) certification from the American Society for Quality. Susanne has now established a consulting business with a mission to provide services to help medical device companies achieve world-class quality and compliance.
Instructor : Edwin Waldbusser
Product Id : 50024

Overview: Human Factors/ Usability is the analysis of how people interact with medical devices. Human Factors/ Usability is the analysis of how people interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process, and validating the effectiveness of the studies will be explained. The various types and methods of human factors analysis will be explained. This process conforms to the new ISO 62366 standard and the new FDA Guidance document.
Edwin Waldbusser is a consultant retired from industry after 20 years in management of development of medical devices (5 patents). He has been consulting in the US and internationally in the areas of design control, risk analysis and software validation for the past 8 years. Mr. Waldbusser has a BS in Mechanical Engineering and an MBA. He is a Lloyds of London certified ISO 9000 Lead Auditor and a member of the Thomson Reuters Expert Witness network.