Validation is an important element of the Quality System Regulations and ISO13485. This course will cover the validation essentials for medical device manufacturers. You will learn about what processes needed to be validated and what steps you need to take to validate processes. Validation is a powerful tool in understanding, optimizing, and controlling manufacturing processes. We will cover the essential steps of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) including tips and best practices.
Why Should You 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 webinar, you will learn how to avoid these problems and use validation concepts to ensure process stability and control. You will learn the benefits and impacts of validation and how it can benefit your customers and your business. We will cover tools and techniques that can help you successfully validate your processes.Areas Covered in the Webinar:
- Purpose, scope, and benefits of process validation
- FDA Expectations, Regulations
- Lessons learned and enforcement case studies
- Common problems and solutions
- When to verify and when to validate
- Steps and checklists for validation
- Linkages within your Quality System
- Master Validation Planning
- Best Practices
- Inspection Preparedness
Who Will Benefit:
- Manufacturing Engineers
- Process Engineers
- Quality Engineers
- Engineering Managers
- Quality Managers
- Auditors
- Compliance Specialists
Course Provider
Susanne Manz,
