Essentials of Validation – IQ, OQ and PQ Protocols

  • Speaker:Susanne Manz
  • Duration:90Min
  • Product Code:GRC-90578

Live Session - How it works

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  • Presentation handouts in pdf format will be emailed to along with the login instructions or few hours before the meeting starts.
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  • Get answer to your queries through interactive Q&A sessions. The Q and A sessions are at the end of the meeting. The expert will complete his/ her presentation and then the phone lines will be open for the audience to discuss your questions.
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  • Certificate of attendance is emailed to you within 6 working days from the date the webinar was completed. If you don’t receive an email within 6 days. Please email our support@grcts.com

Recorded Session - How it works

  • Login Information with Password to view the webinar will be emailed to you within 48 hours from the date the Live webinar was completed. The link to the recording is for a single person use only and it is valid for 6 months or the actual duration the recording was purchased.
  • Please click on the link to access the Recording and type in the password provided in the email.
  • Presentation and other handouts will be emailed to you in a pdf format.

Training CD - How it works

  • Free shipment within 2 working days, from the date the webinar was completed. The presentation and other handouts will be emailed to you in a pdf format if we are unable to attach them in the CD or USB.

(For more information about our products contact +1- 248-233-2049)

If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. Access the recording of the webinar for 6 months. Contact our support for any questions. To prepare an invoice to pay by Check or Wire email us at support@grcts.com.

Certifications: GRCTS Attendance Certificate

Description:

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:

  • Purpose, scope, and benefits of process validation
  • Review common protocol types and the typical information included in each.
  • Common Deficiencies 
  • FDA Expectations, Regulations
  • Lessons Learned and Enforcement Case Studies
  • When to Verify and Validate
  • Process of Verification and Validation
  • Linkages to your Quality System.
  • Summarize Results
  • Master Validation Planning
  • Best Practices and Q n A with Attendees

Who Will Benefit: 

  • Medical Device Companies
  • Manufacturing Engineers
  • Process Engineers
  • Quality Engineers
  • Quality Assurance
  • Engineering Managers
  • Quality Managers
  • Quality Control
  • Production
  • Auditors
  • Equipment vendors
  • Compliance Specialists/ Regulatory.

Instructor 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, Worldwide Director of Quality Engineering, Design Quality, and Director of Corporate Compliance.  

She has traveled extensively throughout the world helping companies understand and improve their Quality Management Systems.  Susanne is a Presidential Scholar and 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 is a Certified Quality Auditor by the American Society for Quality.  She has also served as a judge for the ASQ ITEA awards.  Susanne has now established a consulting business, Manz Consulting LLC, with a mission to provide services to help medical device companies achieve world-class quality and compliance.  

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Available Options

Live Meeting Access Single: Attend the Live Meeting Online from any location

$169

Recording: Unlimited Viewing Access for 6 Months

$229

CD-DVD: Shipped within 2 working days

$309

USB - Shipped within 2 working days

$329

5 Member Group: 5 people can Attend the Live Online Meeting from any location globally

$899

10 Member Group: 10 people can Attend the Live Online Meeting from any location globally

$1,689

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Scrutinizing Test Method Validation (TMV) to Verify the Performance of a Medical Device

Scrutinizing Test Method Validation (TMV) to Verify the Performance of a Medical Device

If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. Access the recording of the webinar for 6 months. Contact our support for any questions. To prepare an invoice to pay by Check or Wire email us at support@grcts.com. Background: Test method validation is an often-confusing requirement for medical devices.  A fundamental issue is the role-reversal between the test method and the product or process it is designed to detect.   For e..

$169

Measurement Uncertainty in Microbiology (+)

Measurement Uncertainty in Microbiology (+)

If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. Access the recording of the webinar for 6 months. Contact our support for any questions. To prepare an invoice to pay by Check or Wire email us at support@grcts.com. Course Description This training program will discuss the concept and application of uncertainty of measurement (MU) as required by ISO/IEC Standard 17025:2005 for laboratory accreditation, from a practical microbiological per..

$189

Quality Control for Microbiological Media and Reagents

Quality Control for Microbiological Media and Reagents

If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. Access the recording of the webinar for 6 months. Contact our support for any questions. To prepare an invoice to pay by Check or Wire email us at support@grcts.com. The webinar will discuss QC best practices and procedures for verifying the suitability and performance characteristics of microbiological media and reagents. Why Should You Attend: Many laboratories are unsure about which ..

$169

21 CFR Part 820 - Quality System Regulation - Applying Principles of Lean Documents and Lean Configuration

21 CFR Part 820 - Quality System Regulation - Applying Principles of Lean Documents and Lean Configuration

The price for the recording is a discounted figure since the recording has a bit of static. The audio of the expert is loud and clear. However, due to static within the meeting. We are obligated to offer the recording at a discounted price. Please contact our support@grcts.com or click on chat below if you have any questions.  Why should you attend: If you are constantly struggling to create, manage, and maintain all of the information found in controlled documents, all of which are o..

$269

Writing and Enforcing Effective SOPs (Standard Operating Procedures)

Writing and Enforcing Effective SOPs (Standard Operating Procedures)

If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. Access the recording of the webinar for 6 months. Contact our support for any questions. To prepare an invoice to pay by Check or Wire email us at support@grcts.com. Overview Almost every paragraph of the Quality System Regulation says that manufacturers shall “establish” procedures”.  This webinar will help you to write clear, unambiguous, and flexible SOPs that accompli..

$169