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 will learn the essentials of validation planning, protocol writing, and change management, and we will also cover tools and techniques that can help you successfully validate your processes.
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 will 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.
Susanne Manz, MBA, MBB, RAC, CQA, is an accomplished leader in the medical device industry with an emphasis on quality, compliance, and six sigma. She has worked at industry-leading companies such as GE, J&J, and Medtronic with an extensive background in quality and compliance for medical devices, including roles as an executive business consultant, worldwide director of product quality, and director of Corporate Compliance.
Sussane is a presidential scholar with a BS in Biomedical Engineering and an MBA from the University of New Mexico. She earned her Black Belt and Master Black Belt certifications with Johnson and Johnson. She also holds Regulatory Affairs Certification (RAC) from RAPS and is a CQA (Certified Quality Auditor) from the American Society for Quality. She has now established a consulting business with a mission to provide services to help medical device companies achieve world-class quality and compliance. Her new book on Medical Device Quality Management Systems – Strategies and Techniques for Improved Efficiency and Effectiveness, is now available at Elsevier and Amazon.