Top Process Validation Mistakes - And How to Avoid Them
Duration : 60 Minutes
Susanne Manz,
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. She has a BS in Biomedical Engineerin Read more
Validation is an important element of the Quality System Regulations and ISO13485. This course will cover 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. We’ll discuss the top mistakes that companies make and how you can avoid them.
Course Objectives:
• The top mistakes people make before starting validation
• Frequently-seen mistakes made during method validation
• Common errors made after process validation work is completed
• Why process development is critical for a good method validation
• Defining the validation process
Why Should You Attend:
Process validation is required per regulation to show regulatory authorities that a process consistently produces a result meeting its predetermined specifications. If not performed properly, process validation can result in delays in product development, or even in product quality issues.
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 how to conduct process validations and how it can benefit your customers and your business. We’ll cover tools and techniques that can help you successfully validate your processes.
Course Outline:
• 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
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
• Manufacturing Engineers
• Process Engineers
• Quality Engineers
• Engineering Managers
• Quality Managers
• Auditors
• Compliance Specialists
• Validation Specialists
• Methods Development Scientists
• QC Analysts
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
