IQ, OQ, PQ - Validation Essentials for Medical Device Manufacturers

Product Id : FDA225
Instructor : Susanne Manz
Jun 04, 2019 1:00 PM ET | 12:00 PM CT | 10:00 AM PT | 90 Minutes


When you are all set for acquiring a new piece of equipment, you will need the exact design specifications for utilizing the materials used in its construction. IQ (Installation Qualification), OQ (Operational Qualification) and PQ (Performance Qualification) work as the validation measures for evaluating the new equipment and testing the materials used in its construction. Validation is an important expectation in the Quality System Regulations and ISO 13485. Failure to validate is a significant cause of 483 observations. Even worse, it can result in customer complaints, adverse events, and recalls.

Join this webinar with expert speaker Susanne Manz where you will learn how to avoid these problems and use of validation concepts to ensure process stability and control. You will learn the benefits and impact of validation and how it can benefit your customers and your business. During the session, Susanne will take up the most reliable tools and techniques that can help successfully validate the processes.

By attending this webinar, you will also learn the processes that need to be validated and what steps you need to take to validate them. You’ll learn the essentials of validation planning, protocol writing, and change management.

Session Highlights:

  • Purpose, scope, and benefits of process validation
  • FDA expectations, regulations
  • Lessons learned and enforcement case studies
  • Common problems and solutions
  • When to verify and when to validate
  • Steps and checklists for validation
  • Linkages within your quality system
  • Master validation planning
  • Best practices
  • Inspection preparedness

Also Includes:

  • Training materials
  • Live Q&A session with the expert speaker
  • Certificate of attendance

Who will Benefit:

  • Manufacturing engineers
  • Process engineers
  • Quality engineers
  • Engineering managers
  • Quality managers
  • Auditors
  • Compliance specialists
Speaker Profile:

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 Engineering and an MBA from the University of NM. She earned her Black Belt and Master Black Belt certifications while at Johnson and Johnson. Ms. Manz also holds a Regulatory Affairs Certification (RAC) from RAPS and a Certified Quality Auditor (CQA) certification 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.

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