Overview:
Validation is an important element of the Quality System Regulations and ISO13485.
This course will cover the requirements the essentials of validation. You'll learn about what processes needed to be validated and what steps you need to take to validate processes.
You'll learn the essentials of validation planning, protocol writing, and change management. We'll cover the steps of Installation Qualification (IQ),Operational Qualification (OQ), and Performance Qualification (PQ) including tips and best practices.
Areas Covered in the Session:
- Purpose, scope, and benefits of process validation
- FDA Expectations, Regulations
- Lessons learned and enforcement case studies
- Common problems
- When to verify and when to validate
- Process and steps for validation
- Linkages to your Quality System
- Master Validation Planning
- Best Practices
Who Will Benefit:
- Manufacturing Engineers
- Process Engineers
- Quality Engineers
- Engineering Managers
- Quality Managers
- Auditors
- Compliance Specialists