Overview:
Validation is an important element of the Quality System Regulations and ISO13485.
Validation is an important element of the Quality System Regulations
and ISO13485. This course will cover validation essentials for medical
device manufacturers. You’ll learn about what processes need 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.
Why you should Attend:
Failure to validate is a significant cause of 483 observations. Even
worse, it can result in customer complaints, adverse events, and even
recalls. In this seminar, you’ll learn how to avoid these problems and
use validation concepts to ensure process stability and control.
You’ll learn the benefits and impacts of validation and how it can
benefit your customers and your business. This seminar will cover tools
and techniques that can help you successfully validate your processes.
Validation can help you to optimize your processes with resulting
improvement in predictability, consistency of outputs, and business
results.
Areas Covered in the Session:
- Purpose, scope, and benefits of process validation
- FDA Expectations, Regulations
- Lessons learned and enforcement case studies
- Common problems and easy solutions
- When to verify and when to validate
- Installation Qualification
- Operational Qualification
- Performance Qualification
- Steps and checklists for validation
- Documentation
- Linkages within your Quality System
- Master Validation Planning
- Best Practices
- Inspection Preparedness
Who Will Benefit:
- Manufacturing Engineers
- Process Engineers
- Quality Engineers
- Design Engineers
- Engineering Managers
- Quality Managers
- Auditors
- Compliance Specialists