WCS Consulting Inc.3190 Stirling Rd, Unit K4, Hollywood, FL 33021,

Hollywood,

Florida,

United States,

ZIP: 33021

Phone: 347 282-5400

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

• Purpose, scope, and benefits of process validation
• FDA Expectations, Regulations
• Lessons Learned and Enforcement Case Studies
• When to Verify and Validate
• Process of Verification and 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

Speaker Bio:
Susanne Manz, MBA, MBB, RAC, CQA is an accomplished leader in the medical device industry with emphasis on quality, compliance, and Six Sigma. She has an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities.