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IQ,OQ,PQ in the Verification and Validation Process

IQ,OQ,PQ in the Verification and Validation Process

  Duration: 90 Minutes

Faculty: Susanne Manz      Level: Intermediate      Course ID: 1150

Overview:

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

Who Will Benefit:

  • Manufacturing Engineers
  • Process Engineers
  • Quality Engineers
  • Engineering Managers
  • Quality Managers
  • Auditors
Recording
$179.00

Access Recording for Life Time

DVD
$199.00

Training DVD will be shipped within 10 business days

USB
$209.00

Training USB will be shipped within 10 business days

Group 5
$599.00

Get 5 Recording Licenses

Group 10
$749.00

Get 10 Recording Licenses

Medical Device Consultant