Verification vs Validation

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Description:

This webinar will focus on the difference between Verification vs Validation and how can we use them to improve the bottom line.

If Verification &Validation are done right, the process and product should always conform unless there is an obvious equipment malfunction or human error. If Design Verification &Validation are done right and only conforming product is released, the customer should be completely satisfied and sales will be predictable. From Management’s POV, that’s not too much to expect for the time and investment allocated to it. However, reality is often much different. Validated processes fail for no obvious reason, causing back orders, loss of customer satisfaction and missed sales predictions. This talk will focus on the differences between these concepts and how to use the information gained to minimize future problems.

Verification and validation activities account for a significant amount of time and resources in the final stages of new product development, and Management’s expectation is that this investment will eventually pay off in terms of product conformance and increased sales. This talk will shed light on the issues behind disappointing studies and how to overcome them.

Participants should have some previous experience with verification and validation activities, but otherwise, this talk is applicable to all levels, especially management, as it covers underlying principles in a simplified format.

Areas to be Covered:

Important definitions and related terms
What these terms have in common & how are they different
Underlying issues that cause validated processes to fail
Requirements for verification and validation and assuring accurate results
Using verification and validation data to achieve process control

Who will Benefit:

This discussion will benefit any organization that performs V&V activities as part of new product development and/or wants to improve the control of their current processes. It should be of interest to
QA and Manufacturing Managers
QA and Manufacturing Engineers
Supervisors
Regulatory Affairs
Research & Development
Quality Auditors
Documentation Department
Anyone responsible for performing or reviewing verification and validation documents

Antony J. DeMarinis

Tony DeMarinis has BS degrees in Biology & Microbiology and a MS in Quality Management. He is currently an independent Consultant specializing in Sterilization, Quality Systems, Auditing, and other Quality Management issues in the medical device and pharmaceutical industries. Previously, Tony was Director of QA/RA at Tunstall Americas for electronic monitoring devices, Quality Manager at Sealed Air for medical packaging, Quality Systems Manager at Davol for implants and surgical devices, Director of Quality Assurance at Scott Laboratories for in-vitro diagnostics and Sr. Microbiologist at the National Cancer Institute.

He is recognized as a Fellow by the American Society for Quality, and he is a Certified Quality Auditor, BioMedical Auditor, Six Sigma Black Belt, Pharmaceutical GMP Professional and Manager for Quality and Organizational Excellence. He also teaches the refresher courses for the CQA and CMQ/OE certification programs through the local ASQ sections. Tony has over 25 years’ experience using quality management techniques and value added auditing including the use of Failure Investigation and Root Cause Analysis to improve processes and products.

This product is currently out of stock and unavailable.

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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance