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