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ESSENTIALS OF VALIDATION - IQ OQ PQ

 * Wednesday

Time:

10:00 AM PST | 01:00 PM EST
Duration:
90 Minutes
Instructor:
Susanne Manz
Webinar Id:
51730


More Trainings by this Expert

Price Details
$149 Live
$299 Corporate Live
$199 Recorded
$399 Corporate Recorded
Combo Offers
Live + Recorded
$299 $348 Live + Recorded
Corporate (Live + Recorded)
$599 $698 Corporate
(Live + Recorded)
Refund Policy

Price Detail Options


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 the requirements and the essentials of validation. 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 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:

 * Purpose, scope, and benefits of process validation
 * FDA Expectations, Regulations
 * Lessons learned and enforcement case studies
 * Common problems
 * When to verify and when to validate
 * Process and steps for validation
 * Linkages to your Quality System
 * Master Validation Planning
 * Best Practices


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. 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.

View More Trainings by this Speaker





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Essentials of Validation - IQ OQ PQ

by : Susanne Manz

Date : Wednesday, 30. November 2022 10:00 AM PST | 01:00 PM EST

Duration : 90 Minutes

Price : 149,00 $

View Details




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