Webinar On Design Verification, Validation and Testing for Medical Devices

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Design Verification, Validation and Testing for
Medical Devices
Product Id
MD1091
Category
Medical Devices
Scheduled On
Friday, June 13, 2014 at 1300 Hrs
Duration
75 Minutes
Speaker
Meena Chettiar
To register for this webinar please visit our
website www.compliancetrainings.com
Webinar Description
Design Control is an integral part of any quality
system in regulated industries. FDA Quality
System regulation, Quality System Inspection
Techniques (QSR and QSIT) and ISO 13485 have
specific product verification and validation
requirements that must be fulfilled in the
medical device industry. FDA is getting more and
more stringent about product design requirements
for risk management and to fulfill its mandate
for safety and efficacy of all medical devices.
The design controls are now being expected from
outside equipment manufacturers (OEM) and
suppliers to the medical device industry. This
webinar will educate you on the key areas that
you need to focus on to fulfill the design
control requirements for your medical device.
Areas Covered in the Session
? ? ? ? ? ? ? ? ? ? ? ?
Product development process overview Applicable
design verification and validation
requirements Testing requirements including the
pertinent ISO guidelines Translation of user
requirements into design inputs and role of
testing and regulatory requirements Fulfilling
critical to customer and critical to quality
requirements Design verification and design
validation activity cycles Traceability and risk
management at all stages Design outputs and
documentation in DMR (Device Master Records) and
DHR (Device History Records) Test requirements
to fulfil acceptance criteria for final
products How to withstand regulatory scrutiny How
are changes and their effects controlled and
documented during the device life cycle? Summary
Who Will Benefit
? ? ? ? ? ?
Senior management Middle management Research
Development Quality Engineers Manufacturing
Engineers Regulatory Affairs Professionals
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Quality Assurance Quality Control
Personnel Device Design Team Device Development
Team Device Manufacturing Team Verification
and/or Validation planning, execution and
documentation for devices. Start up Company
Leaders
To register our webinar visit our website
www.compliancetrainings.com
Speaker Profile
Meena Chettiar 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.
She is Senior Supplier Quality Engineer at
Covidien in Plymouth, Minnesota, USA. Prior to
this position, Meena served as a Senior Quality
Associate (Lead Auditor and CAPA Coordinator) at
Baxter Bio Surgery in St. Paul, MN. Meena worked
as a Senior Quality 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. 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
served as an instructor for these ASQ
certification classes since 2006.
Ms. Chettiar received her 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 very
happy to present webinars for Compliance Trainings
and continue to contribute towards quality and
global regulatory compliance for regulated
industries