About the Conference

Presented as a Virtual Conference, plan to attend this conference from your desktop.

Production and Process Controls non-conformances are among the most frequent cause of FDA and notified body enforcement actions. In addition to avoiding regulatory challenges, there are compelling operational reasons for characterizing the manufacturing process, identifying key inputs and process parameters, and ensuring that inspection and testing activities are robust and reliable.

This highly interactive program convenes government, industry, and other experts to discuss the challenges of Production and Process Validation and Test Method Validation, and practical approaches to meeting them.

Topics will include:

  • FDA / GHTF / IMDRF alignment on validation requirements
  • The role of risk management in validation
  • Determination of appropriate acceptance criteria
  • Attribute and variable sampling plans for sample size selection
  • The importance of component pedigree
  • Statistical techniques for data analysis
  • Distribution fitting
  • Gauge R&R
  • Attribute test method validation
  • Selecting the optimal P to T ratio
  • Design of Experiments in Operational Qualification
  • Considerations in Installation Qualification

Who should attend:

  • Medical device company business executives
  • Executives in medical device quality and design assurance
  • Manufacturing and design engineers
  • Healthcare organizations with strategic investments in the medical device manufacturing sector
  • Suppliers to medical device manufacturers
  • Companies with legacy products currently on the market

CEU Information

Attendees can earn CEUs. 1 hour of the conference = .1 CEU. MedTech Intelligence will provide you a Certificate of Attendance with the amount of CEU's earned about three weeks after the conference.

MTI's conference CEUs can be applied to your Regulatory Affairs Certification.


  • Where

  • Online
    All times are Eastern Standard Time

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