This webinar will help you understand specific product verification and validation requirements for medical devices to comply with ISO 13485: 2016 and FDA quality system regulations. It will focus on the topics such as product development process, traceability and risk management at all stages, design outputs and documentation in DMR and DHR, design verification and design validation activity cycles and more.
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: 2016 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 fulfil 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.
The goal of this webinar is to educate you on the key areas that you need to focus on to fulfil the design control requirements for your medical device.Areas Covered in the Webinar:
Principal Quality Engineer, Freudenberg Medical
Meena Chettiar is currently working as a Principal Product Development Quality engineer at Freudenberg Medical in Minnesota, USA. Meena has worked in several capacities over the past 20 years in several high level Quality and Regulatory Management positions at pharmaceutical and medical device companies such as ProMed Pharma, Covidien, Teva Pharmaceuticals and NAMSA. She has also worked as QC lab supervisor at Land O’ Lakes in Minnesota and for Agriculture and Health Canada in several technical capacities for about 10 years.
Meena has participated as the lead supplier/internal/GMP auditor in several compliance audits in the US, India, Costa Rica, Mexico and Puerto Rico. She 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. She is a certified instructor for ASQ learning institute for CBA and has been an adjunct instructor for Medical Technology Quality graduate program for St. Cloud State University in Minnesota since 2013. She is a coauthor of the CBA (Certified Biomedical Auditor) Primer for the Quality Council of Indiana.
Ms. Chettiar received her M.S. in Regulatory Affairs for Medical Devices in Minnesota, 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.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. FDATrainingAlert would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.
Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.
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