Process Validation for Medical Devices - Webinar

Date: Flexible - per your schedule
Presented by: Jayme Lahey
Presentation time: 2 hours
Cost: $399.00
for first attendee (+ $50 for each additional attendee)

Includes eBook "Straight Talk on Process Validation"

The reasons medical device manufacturers need to perform process validation are two-fold. The first reason is to satisfy FDA requirements. Although this alone would be a sufficient reason, another key reason to perform process validation is to ensure BUSINESS SUCCESS!

Attend this webinar and learn the principles and application of successful process validation. Whether you are new to process validation or want to refine and improve your existing program, you will benefit from this informative, practical webinar. You will learn how the current FDA regulations, interpretations and guidelines affect you and how to develop a validation program consistent with compliance and business success.

Who Should Attend?
Professionals directly involved in the development and manufacturing of medical devices and meeting the FDA's quality system requirements. Individuals associated with regulatory affairs, quality assurance, process development or manufacturing will find this informative webinar extremely valuable.

System Requirements:
Attendees will need high speed internet access and audio. The webinar will be run with GoToMeeting software. A quick (approximately 2 minute) install will be needed to view the webinar. This may be done during registration or upon webinar log-in.

Webinar Outline

  • Brief History of Validation
  • Does Your Company Need to Do Process Validation?
  • Process Validation Lifecycle
  • Definitions
    • What is Process Validation?
    • Verification
    • Objective Evidence
    • Process Validation Protocol
  • Validation Economics
  • How to Comply in a Cost-Effective Manner?
  • What is a Validation Master Plan (VMP)?
  • Why VMP is key.
  • Elements of Process Validation
  • Types of Validatons
    • Prospective
    • Concurrent
    • Retrospective
  • Revalidation
  • Processes Which Should Be Validated
  • Processes Which May Be Verified
  • What are the Steps to Validation of a Process?
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)
  • On-going Control
  • Key Statistical Tools to Supplement Your Efforts
  • What can go wrong? How to resolve in an acceptable manner.
  • Conclusion

About the Presenters
Bruce Tive is a Group Manager at a major medical device company. Bruce has over 30 years of medical device experience at various medical device companies in the areas of manufacturing engineering, packaging and validation. Bruce has a Master's of Science in Quality Assurance. He has trained engineers, product managers, and product development engineers in the various aspects of validation. His interactive style will help you grasp the material and feel confident in its application.

Robert Launsby has taught thousands of students Design of Experiments techniques and hundreds in the area of Six Sigma. Bob has consulted with numerous companies in the area of FDA protocols for Process Validation. He is co-author of "Process Validation for Business Success", "Design for Six Sigma", "Engineering Today's Designed Experiments", "Understanding Industrial Designed Experiments" and "Experimental Design for Injection Molding". Bob's presentations are lively and informative. His examples are practical and thought provoking.

For further information or questions, please contact Launsby Consulting at 1-719-282-1143.

To Order:
Price is $399.00. Call Launsby Consulting at 719-282-1143 or click on the button below. You will then be contacted regarding what date and time work best for you to attend this webinar.


Click Below To Order


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