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 fulfill its mandate for safety and efficacy of all medical devices.
The design controls are now being expected from outside equipment manufacturers (OEM) and all 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 and testing requirements for your medical device at various phases of your product development.
Areas Covered in the Session :
- Product development process overview
- Applicable design verification and validation requirements
- Testing requirements including the pertinent ISO Standards
- Translation of user requirements into design inputs
- Role of testing and regulatory requirements
- Focusing on critical to customer and 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)
- Proof for how design outputs meet functional and operational requirements
- Compatibility of the design with components and other accessories
- Test requirements to fulfill acceptance criteria for final products
- How to withstand regulatory scrutiny
- How are changes and their effects controlled and documented during the device life cycle?
Who Should Attend:
- Senior management
- Middle management
- Research & Development
- Quality Engineers
- Manufacturing Engineers
- Regulatory Affairs Professionals
- 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
Course Director: MEENA CHETTIAR
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.