Duration: 3 Hour


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Validation is an essential element of the Quality System Regulations and ISO 13485. This course dwells into the processes that need to be validated and what steps are needed to validate the processes. You’ll also learn the essentials of validation planning, protocol writing, and change management.

We’ll take a deep dive into all the steps of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) including industry tips and best practices. This session will discuss the considerations of IQ, OQ, and PQ and their counterparts for processes, equipment (production and test), product, including cGMP e-records / e-signatures.

Why You Should Attend:

Failure to validate is a sure-fire way to a 483 observation. Worse still, it can result in customer complaints, adverse events, and even product recalls. This 3-hour virtual seminar will guide you on how to avoid these problems and use validation concepts to ensure process stability and control. Effective validation can benefit your customers and your business; learn the benefits and impacts of validation from this session. We’ll cover how to effectively validate your processes by using current tools and techniques.

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

Course Director: 

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.