Webinar ID:   MD3589

3-Hour Virtual Seminar on IQ, OQ, PQ in the Verification and Validation Process

 RECORDED
  3 Hours

Validation is an important element of the Quality System Regulations and ISO 13485. This course will cover what processes needed to be validated and what steps you need to take to validate processes. You’ll also learn the essentials of validation planning, protocol writing, and change management.

We’ll also cover the steps of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) including tips and best practices. This webinar will discuss the Consideration of IQ, OQ, and PQ and their equivalents for processes, equipment (production and test), product, and cGMP e-records / e-signatures.

Why You Should 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.

Areas Covered in the Session :

  • IQ, OQ, and PQ, major components of robust Verification and Validation programs – Regulatory requirements
  • The Master Validation Plan(s)
  • Individual V&V Plans and their execution
  • Product Verification and Validation
  • Process and Equipment V&V, including software
  • QMS V&V and 21 CFR Part 11
  • When / How to Use DQ, IQ, OQ, PQ
  • Incorporating the Hazard Analysis / Risk Management tools of ISO 14971 or ICH Q9
Who Should Attend:

  • Quality Assurance Departments
  • Research and Development Departments
  • Regulatory Affairs Departments
  • Manufacturing Departments
  • Engineering Departments
  • Operations Departments
  • Production Departments
  • Validation Departments
  • Software Departments
  • Documentation Departments
  • Consultants
  • cGMP Instructors

MD3589

Susanne Manz

Susanne Manz 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 Engineering and an MBA from the University of NM. She earned her Black Belt and Master Black Belt certifications while at Johnson and Johnson.

Susanne also holds Regulatory Affairs Certification (RAC) from RAPS and Certified Quality Auditor (CQA) certification from the American Society for Quality. Susanne has now established a consulting business with a mission to provide services to help medical device companies achieve world-class quality and compliance.