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

Susanne Manz Instructor:
Susanne Manz 
Monday, August 22, 2022
09:00 AM PDT | 12:00 PM EDT
3 Hours
Webinar ID: 500582

More Trainings by this Expert

Price Details
Live Webinar
$299 One Attendee
$499 Corporate Live
Recorded Webinar
$349 One Attendee
$549 Corporate Recorded
Combo Offers
Live + Recorded
$559 $648 Live + Recorded
Corporate (Live + Recorded)
$799 $1048 Corporate
(Live + Recorded)

Live: One Dial-in One Attendee

Corporate Live: Any number of participants

Recorded: Access recorded version, only for one participant unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)

Corporate Recorded: Access recorded version, Any number of participants unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)

Overview:

Validation is an important element of the Quality System Regulations and ISO13485. This course will cover validation essentials for medical device manufacturers. You’ll learn about what processes need 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.

Why should you 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 seminar, 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. This seminar will cover tools and techniques that can help you successfully validate your processes. Validation can help you to optimize your processes with resulting improvement in predictability, consistency of outputs, and business results.

Areas Covered in the Session:

  • Purpose, scope, and benefits of process validation
  • FDA Expectations, Regulations
  • Lessons learned and enforcement case studies
  • Common problems and easy solutions
  • When to verify and when to validate
  • Installation Qualification
  • Operational Qualification
  • Performance Qualification
  • Steps and checklists for validation
  • Documentation
  • Linkages within your Quality System
  • Master Validation Planning
  • Best Practices
  • Inspection Preparedness

Who Will Benefit:
  • Manufacturing Engineers
  • Process Engineers
  • Quality Engineers
  • Design 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. While at GE, J&J, and Medtronic, Susanne worked in various world-wide roles including Executive Business Consultant, WW Director of Quality Engineering and, Design Quality, and Director of Corporate Compliance. Susanne 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.


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