Process Validation for Medical Device

Medical device manufacturers need to perform process validation(s). The reasons are two-old: satisfy FDA requirements, and ensure business success. Attend 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 seminar. 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.

• Learning Objectives
  • Familiarize with the latest FDA guidelines and interpretations of product/process validation.
  • Recognize how Validation Master Plans help the planning process.
  • Differentiate between qualification, verification and validation.
  • Identify if (and when) validations are required.
  • Determine what activities must be completed prior to conducting a validation (confirming) event.
  • Learn how to conduct and document a validation event.
  • Understand what to do when things go wrong (What if's!).
  • Use peer feedback to learn about your own planned or completed validation programs including specific issues and questions.
• Who Should Attend

  Quality managers, quality engineers and quality technicians involved in the development and manufacturing of medical devices. Professionals directly involved in meeting the FDA’s quality system requirements such as those in regulatory affairs, quality assurance, process development or manufacturing.

• More Information

  Prerequisites

  None

  Course Data

  • CEU Hours: 0.70
  • ASQ RU: 0.70
  • Provider: ASQ
  • Course ID: PVMD
  • Course Length: 7 hours
  • Cancellation Policy
• Instructors
  • Robert G. Launsby
  • Bruce Tive