This course will cover validation essentials for medical device manufacturers. Attendees will 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.
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’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. We’ll 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 Webinar:
- 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
- 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
Speaker
Susanne ManzCourse Provider
Susanne Manz,
