Requirements of Validation – IQ, OQ and PQ Protocols

  • Speaker:Susanne Manz
  • Date: 13th December 2017 10:00 AM PST | 01:00 PM EST
  • Duration:90Min
  • Product Code:GRC-90196

$249

refer

Refer Friend's


Live Session - How it works

  • Username and Password will be sent to you 24 hours prior to the webinar.
  • Presentation handouts in pdf format will be mailed to you.
  • Login to the session using the username and password provided to you.
  • Get answer to your queries through interactive Q&A sessions via chat.
  • Please let us know your thoughts and views at the end of webinar, your valuable feedback will help us improve.
  • Get certification of attendance.

Recorded Session - How it works

  • Login Information with Password to view the webinar, 24 hours after the Live webinar (link valid for 6 months).
  • A link will be provided to you upon purchase of the recorded session.
  • Please click on the link to access the session.
  • Presentation handouts in pdf format will be mailed to you.
  • Get certification of attendance.

Training CD - How it works

  • Free shipment within 72 Hours, from the date of webinar completion.

(More about our products contact +1- 248-233-2049)

Contact Support for In person and or Corporate Training. The dates will be confirmed depending on speaker's availability. 

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.  

Available Options

Recording: Access it for 6 months from any location

$249

CD: Shipped within 2 working days

$349

5 Member Group: Access the Live Meeting online from any location globally

$1,429

10 Member group: Access the Live Meeting online from any location globally

$2,369
For discounts and offers call support

Related Products

Root Cause Analysis and CAPA

Root Cause Analysis and CAPA

We offer face to face and online training. If you have 5 or more people interested in learning this topic. Contact our support to set up a date. Description: Conducting an effective root cause analysis can be a daunting task. And without a good root cause analysis, your CAPA will not result in the desired improvement. This webinar will give you insights and lessons learned from an industry expert with over 30 years’ experience. You will learn how to get permanent resolution to your seri..

$249

Complaint Handling and Medical Device Reporting

Complaint Handling and Medical Device Reporting

Description: Complaint Handling and Medical Device Reporting are considered critical processes by the FDA in maintaining the public safety. Because they are so critical the FDA frequently inspects these areas in great detail. More importantly, complaints can be also be an early warning of issues with your products and customer problems. It is vital to have efficient and effective processes for managing, analyzing, trending, and reporting product problems. This webinar will cover the basic..

$239