Iso 13485: 2016 - Understanding and Implementing The International Medical Device Quality Standard

Meena Chettiar

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This presentation will cover everything you ever wanted to know about the International Medical Device Standard ISO 13485:2016 Released on 01 March 2016 so you can start the gap assessment and make your quality system compliant to the new standard. Participants will gain a thorough insight into the specific quality system requirements of the all new International ISO 13485:2016 Quality System Standard requirements for Medical Devices. This extremely informative webinar will truly build your ISO 13485 knowledge from the fundamental quality principles. It will help you grow into fulfilling the quality and regulatory requirements as a professional working for medical device manufacturers of fully assembled devices and global suppliers manufacturing critical parts for the medical device industry for FDA registered medical device companies. Changes made to the key elements of this international standard will be discussed to pave the path for implementation of the changes in your quality system for manufacturing of your medical devices or parts for the medical device industry.

Course Objective

  • Current vs Future expectations in the ISO 13485 world for your medical device
  • A quick comparison of how the new standard is harmonized with 21 CRF 820 and GHTF Documents will be made
  • Alignment of the standard to cater to the Medical Device Single Audit Program MDSAP) will be discussed
  • Extension of the quality system rand risk management requirements for the life cycle of your medical device
  • Incorporation of customer feedback and additional regulatory reporting needs for the new standards
  • Alignment with ISO 9001 and discussion of timeline for full implementation of ISO 13485: 2016

Course Outline

  • Quality Management System(QMS) Requirements of ISO 13485: 2016 compared to ISO 13485: 2003
  • Risk Based approach to all aspects of your QMS
  • Changes to Management responsibility including expectations for management review
  • Elevation in Competence and Training requirements
  • Planning  ( Design and Development including transfer) and Production controls and documentations needed
  • Elevation in CAPA Process Expectations
  • Expectations in the area of Communication with Regulatory Authorities
  • Changes to Supplier Management Requirements for Risk Management in Purchasing
  • Correlation of the new ISO 13485 requirements to FDA QSR 21 CFR 820 requirements

Target Audience

  • Audit and Compliance Personnel / Risk Managers.
  • Medical Device QA Professionals
  • Design Engineers, R&D Engineers
  • Upper Management in Medical Device Companies
  • Supplier and Purchasing Departments in Device Companies

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Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment

Recorded video

Recorded video session

Speaker: Meena Chettiar,

Ms. Chettiar received her M.S. in Regulatory Affairs for Medical Devices in Minnesota, USA, and M.A.SC in Chemical Engineering from University of British Columbia in Canada and her B.S. and M.S in Applied Chemistry from the University of Madras, India. Ms. Chettiar recently completed graduate certification at St. Cloud State University in Applied Clinical Research Program focusing on medical devices. Meena is currently working as a Quality and Regulatory Manager at ProMed Pharma, Medical and combination device manufacturer. Meena has worked as a Senior Supplier Quality Engineer for Covidien with drug coated balloons and guide wires, for Baxter Bio Surgery, as a Senior Quality Manager at Teva Pharmaceuticals for over 10 years and as QC lab supervisor at Land O' Lakes. Meena has also worked for Agriculture and Health Canada in several technical capacities for about 10 years. Meena has played a key role in quality system implementations in the food, pharmaceutical, and medical device industries. Meena has participated as the lead supplier/internal/GMP auditor in several compliance audits in the US and abroad. Meena is the Vice chair of member development for MNASQ (American Society for Quality) and is ASQ certified CQA (Certified Quality Auditor), CBA (Certified Biomedical Auditor), CQIA (Certified Quality Improvement Associate), and CMQ/OE (Certified Manager of Quality/Organizational Excellence). She has served as an instructor for these ASQ certification classes since 2006. She is a certified instructor for ASQ learning institute for CBA and an adjunct instructor for Medical Technology Quality graduate program for St. Cloud State University in Minnesota. Meena is a coauthor of the CBA (Certified Biomedical Auditor) Primer for the Quality Council of Indiana, used for certification of medical device professionals on the compliance standard requirements. Meena is now working on the Supplier Quality Certification Handbook team.

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