Effective Quality by Design (QbD) 2018 is a webinar that covers topics such as:
- Major considerations in the regulatory requirements for product design
- Unique product design and development requirements
- Simplifying the planning and execution phase of your product
- Insight into the GMP regulations
- Emerging medical device and pharma development
- Quality System requirements for your Design Control System
- 21 CFR 820, 210/211 and ISO 13485
- Design Control and manufacturing requirements per ICH Guidelines
- Risk-based Assessment
- Currently available FDA Guidance Documents
- Solid identification and documentation of root cause
- Essential component of a well-documented quality system
- Proof of evidence needed by regulators
- What data should you gather for each stage of product development
- How to sustain the life cycle of your medical product
Effective Quality by Design (QbD) 2018 is intended for:
- Process Engineering Departments
- Manufacturing Departments
- Design Assurance Departments
- Research and Development Departments
- Quality Control Departments
- Quality Assurance Departments
- Regulatory Affairs Departments
- Document Control Departments
- QbD Consultants
