Navigating your way through ISO 13485

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Description :

ISO 13485 is the International Standard that specifies the regulatory requirements for medical device Quality Management System (QMS). The purpose of this webinar on ISO 13485 is for Quality management system implementers,Quality/regulatory managers and bio medical auditors’ and auditors from Food/Pharma(who are hoping to make the transition into the medical device arena) to gain a thorough understanding of the requirements of ISO 13485 to:
Carefully attend to every aspect of the standard requirements for their medical devices in their QMS
Establish internal standard practices to fulfill the requirements of the standard
Consistently meet and exceed customer and regulatory requirements per this international standard for their medical devices
Understand how your commitment to these ISO standard requirements will facilitate your navigating your way through the harmonized international arena to expand your product marketing strategies at a global level from countries such as Canada, Australia, Brazil, India and China.

You will gain a thorough insight into the specific auditing requirements of the International ISO 13485 Standard requirements for medical devices. This class will truly build your knowledge from the fundamental principles and help you grow into fulfilling the regulatory requirements as a product developer, manufacturer, auditee for external FDA type of audits and serve as an auditor (internal or supplier auditor). The webinar will also focus on the major difference in expectations between FDA Quality System Regulations and Quality System inspection Techniques (QSR and QSIT) and ISO 13485 for globally distributed products.

Areas Covered in the Session :

Fundamental requirements of ISO 13485 and related biomedical standards that medical device companies need to comply with for key areas like:
Document control
Purchasing Controls
Production controls
Identification and Traceability
Post Market Surveillance.
How does ISO 13485 differ from FDA QSR 21 CFR 820 requirements ?

Regulatory expectations of other major growing geographies in the world and how these markets can be prepared to be audited to fulfill ISO 13485 expectations and conduct audits for ISO 13485 Requirements.

Who Will Benefit:

This course will be especially helpful to auditors who would like a deeper understanding of the ever growing medical device regulations particularly those who transitioned from other regulated industries such as pharma/nutraceuticals and food industries and Quality/Regulatory Managers, Supervisors, Department leads, Manufacturing Engineers associated with
Quality Assurance
Quality Control
Supplier Management
Document Control
Internal Auditors
Supplier Auditors
Suppliers to medical device industry
Internal Auditors
Supply Chain Auditors
R&D Engineers
Production Leads and Managers

Meena Chettiar currently works as a Quality and regulatory Manager at ProMed Pharma in Minneapolis. Meena has worked as a Senior Supplier quality engineer at Covidien, Senior Quality Associate (Lead Auditor and CAPA Coordinator) at Baxter Bio Surgery in St. Paul, MN. Meena worked as a Senior Quality Control Manager at Teva Pharmaceuticals for over 10 years and as Instrumentation lab supervisor at Land O’ Lakes. Meena has also worked for Agriculture and Health Canada in several technical capacities for about 10 years before immigrating to the United States.

Meena made the transition to the medical device industry after completing a MS in Regulatory Affairs for Medical Devices through St. Cloud State University in 2010. Meena has played a key role in quality system implementations in the food, pharma, and medical device industries. Meena has participated as the lead supplier/internal/GMP auditor in several Compliance audits in the US and abroad. She has a strong auditing background in the pharmaceutical and medical device auditing. Meena is a senior member of ASQ (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 been serving as an instructor for these ASQ certification classes since 2006 and has conducted quality and medical device related training classes in her current position at Baxter.

Meena is a coauthor of the CBA (Certified Biomedical Auditor) primer for the Quality Council of Indiana. She is currently an adjunct instructor for the medical technology quality program at St. Cloud State University in Minnesota. Ms. Chettiar received her M.S Regulatory Affairs and Services for Medical Devices from St. Cloud State, Minnesota, M.S. in Chemical engineering from University of British Columbia and her B.S. and M.S in Applied Chemistry from the University of Madras, India. Meena is happy to teach webinars for the Compliance Trainings and continue to contribute towards quality and regulatory compliance.

This product is currently out of stock and unavailable.

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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance