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Nice response to my questions and good suggestions for moving forward.

Some of these sessions are too basic - this one had a good mix of basic and details. The tips are helpful. One comment: a little more discussion regarding the use of Detection in FMEAs would be useful since many do not advocate its use. Thanks,

I especially liked that the Q&A session after the webinar was long enough to not only address my own questions but also to learn from the questions from the other participants in the webinar.

Very thorough understanding of the history/progression of the guidances, and very helpful evaluation of current and potential directions. Excellent presentation skills, very engaging.



Developing a Complete Product Quality Plan

Global CompliancePanel
Global CompliancePanel
Training Options
 Duration: 60 Minutes  
Recorded Access recorded version only for one participant; unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
Price: $295.00
Global CompliancePanel
Global CompliancePanel
Customer Testimonials
Instructor Albert Cefalo
Product Id 600175

Overview: The bridge between Product Concept and Customer delivery of a product, whether it be a medical device, a component or a commercial product, is the Product Quality Plan.

The Quality Plan provides the frame work for all of the Quality management System (QMS) elements which will be required for the product at hand.  Many times there are overlooked, incomplete, or improperly documented processes or documents which are due to poor planning. A properly defined Quality Plan will provide the checks and balances between the Operational Document (SOP) processes and the Product Specific processes. This webinar session will provide the participant with a descriptive outline of what is required in a clear and concise Product Quality Plan.

Areas Covered in the Session: Elements of a Quality Assurance Plan, including:

  • Management Responsibilities
  • Verification and Validation Planning
  • Test Planning
  • Device History Records
  • Post-Market Surveillance

Who Will Benefit:

  • Design Engineers
  • Quality Assurance Personnel
  • Program Managers
  • Manufacturing Engineers
  • Regulatory Personnel
  • Engineering Managers
  • Product Group Managers
  • IT Managers



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