Webinars > All COMPLIANCE Categories > Compliance Courses Webinars

Compliance 4 All
Compliance 4 All presents

Virtual Classroom (Live) Essentials of Validation - IQ, OQ, PQ Webinar

In this webinar you will learn the benefits and impacts of validation and how it can benefit your customers and your business, And also you will learn the essentials of validation planning, protocol writing, and change management.

Course Description/Agenda


Validation is an important element of the Quality System Regulations and ISO13485. This course will cover the requirements the essentials of validation. 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
  • 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
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.

 

More Webinar Information

Compliance 4 All
Compliance 4 All

Course Summary

In this webinar you will learn the benefits and impacts of validation and how it can benefit your customers and your business, And also you will learn the essentials of validation planning, protocol writing, and change management.

Delivery Method

Virtual Classroom (Live) Virtual Classroom (Live)

Who Should Attend

• Manufacturing Engineers • Process Engineers • Quality Engineers • Engineering Managers • Quality Managers • Auditors • Compliance Specialists

 
Search similar training
Email this page
Print this document
 

Webinar Details

7/24/2019 - 7/24/2019
Tuition: $150

see all dates

 

Frequently Asked
Questions

Payment Options
Bill Me/Invoice
Credit Card

Register
Online
Fax Form

Availability
Select a date from the list at the bottom of the page for specific information about that class.

Other Information
Virtual Classroom (Live)

All Date/Location Information

7/24/2019-7/24/2019 at 10:00:00 AM PDT