This webinar will cover Risk Management per ISO 14971 throughout the product lifecycle. Risk Management is an important process to methodically and effectively identifying and mitigating risks in the product design and manufacturing processes. A robust process to identify hazards and associated harm throughout the product life cycle is critical to providing safe and effective products for your customers. This webinar will help you build an efficient and effective process for risk management.
Risk Management is a critical aspect of ensuring medical devices are safe and effective for intended uses. This course will help you understand the regulatory requirements and how to create processes and procedures to implement them. You’ll learned techniques that can help you identify hazards and potential harms. You’ll learned how to mitigate risk and effectively monitor risk to ensure your customers receive safe and effective products. A rigorous risk management process can prevent serious quality problems and costs for your company.
Areas Covered in the Session :
- Overview and Definitions
- FDA Expectations
- ISO14971
- Linkages to Design Controls, Production Controls, Investigations, and CAPA
- Risk Management throughout the product lifecycle. Common Mistakes
- Best Practices
Who Will Benefit:
- Due Diligence Teams
- Quality Engineers
- Compliance Departments
- Quality Departments
- General Managers
- Design Engineers
- Research & Development Departments
- Product Development Leaders
- Product Development Project Managers
- Auditors