Understanding and Overcoming Challenges Encountered in Implementing the New ISO 13485:2016 Standard for Medical Device Quality Systems

Duration: 75 Minutes
You 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 knowledge of the new ISO standard from the point of performing a risk based gap assessment followed by understanding the key challenges posed by this new "universally accepted" medical device standard. It will help you to fulfill the new 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. Key challenges posed to the medical device industry by this international standard will be discussed to pave the path for implementation of the changes in your organization.
New ISO 13485:2016
Instructor: Meena Chettiar
Product ID: 507815
Objectives of the Presentation
You will benefit from the following key knowledge aspects:
  • A brief overview of the Quality Management System(QMS) requirements of ISO 13485: 2016
  • Risk Based approach to implementing and incorporating the changes into your QMS
  • Come up with a schedule and allocate resources based on the gap assessment for your company
  • Competence and training requirements and other key considerations
  • What is changing in planning (Design and Development including transfer) and production controls
  • What is changing in CAPA expectations
  • Changes to communication with regulatory authorities
  • Key expectations per the new standard for Supplier Management
  • Correlation to FDA QSR 21 CFR 820 requirements and why this new standard is the new "universal standard"
Why Should you Attend
You must attend this unique webinar presented by an expert trainer to add all the necessary tools to your quality, risk management, auditing and regulatory tool kit and lay the foundation to make the switch from ISO 13485: 2003 to the new ISO 13485:2016 Quality System Standard requirements for Medical Devices. Learning about the scope of the changes including the process of performing a gap assessment of your current quality system will help you to make a smooth seamless transition into the new requirements of this key international standard. Understanding the common challenges encountered in the industry and implementation of the standard requirements will help you gain an edge in the arena of competitive global medical device marketing.

Areas Covered
  • Current vs Future of the ISO 13485 world: Risk based gap assessment
  • 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)
  • Extension of the quality system requirements to the life cycle of the medical device
  • Incorporation of changes to key areas such as customer feedback, Supplier management and CAPA
  • Alignment with ISO 9001 and discussion of timeline for full implementation of ISO 13485: 2016
Who will Benefit
This webinar will benefit Medical Device Company Managers, Supervisors, Leads, Specialists, Engineers and Groups in Department of:
  • Quality Assurance
  • Design Engineers
  • Research & Development
  • Quality Control
  • Supplier Management
  • Upper Management
Topic Background
A thorough understanding of the challenges involved in transitioning to the new ISO 13485:2016 requirements will help facilitate your performance of the gap assessment for navigating your way through the harmonized international standard arena. It will give you an edge to expanding your product marketing strategies through early implementation of the global requirements of this very important medical device standard.
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  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Ms. Chettiar has a very strong background in Quality in the FDA regulated industries. 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 is also very knowledgeable in Clinical Research auditing for medical devices and pharmaceutical products.

Meena is currently working as a Senior Associate at NAMSA and is the Founder and Principle Consultant of MNQ Consulting Services LLC. Meena has worked as Quality and Regulatory Manager at ProMed Pharma, Medical and combination device manufacturer, 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 performed mock QSIT Audits and has responded to several FDA 483s.

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, Canada, Puerto Rico and Costa Rica. Meena is the Chair elect for MNASQ (American Society for Quality) this year. Meena 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).

Meena 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 and is very passionate about Installation and growth of Quality Systems in general.
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