Incorporating a strong quality system during pharmaceutical drugs and medical device design and development by understanding the unique product design and development requirements for final approval and marketing of medical devices and pharmaceuticals through global regulating bodies such as US FDA.
Large and small medical device and pharmaceutical companies have a challenge in dealing with initial stages of a successful product development, specifically in performing a timely, unbiased, scientifically sound documentation of early stages of their discovery. Verification, Validation and Testing after designing their product incorporating quality at each stage of design is a regulatory requirement.
This webinar will pave a solid path to those who want to ensure making their QbD (Quality by Design) the strongest link in their quality system and see their product launched successfully in the market for patients.
Areas Covered in the Session :
- Unique product design and development requirements
- Major considerations in the regulatory requirements for product design
- Insight into the GMP regulations
- Simplifying the planning and execution phase of your product
- Quality System requirements for your Design Control System
- Emerging medical device and pharma development
- Design Control and manufacturing requirements per ICH Guidelines
- 21 CFR 820, 210/211 and ISO 13485
- Currently available FDA Guidance Documents
- Risk-based Assessment
- Essential component of a well-documented quality system
- Solid identification and documentation of root cause
- What data should you gather for each stage of product development
- Proof of evidence needed by regulators
- How to sustain the life cycle of your medical product
Who Should Attend:
- Manufacturing Departments
- Process Engineering Departments
- Research and Development Departments
- Design Assurance Departments
- Quality Assurance Departments
- Quality Control Departments
- Document Control Departments
- Regulatory Affairs Departments
- QbD Consultants
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.