Additive Manufacturing (AM) or 3D Printing for manufacturing of medical devices is a new and rapidly expanding field, with rapidly expanding regulatory concerns. What is it? What are US FDA stated concerns? This webinar will focus on the key elements of AM, the concerns, and a recent Dec 2017 guidance document on the subject. Medical device companies have begun adopting additive manufacturing, also known as 3D printing, to create devices that were previously impossible to make, personalized to the patient, or both. 3D printing can create many types of medical devices from metals, plastics, hydrogels, and even biological materials. New terms, materials usage / application, unique device construction, all raise new metrics and quality concerns. The FDA recognizes this growing technology and customization, and future possible organ replacement potential as well, and has formed their own Additive Manufacturing of Medical Products (AMMP) area within the FDA with state of the art manufacturing equipment and research methods to try to get ahead of the curve. They have also published an initial start at industry guidance with a new document. Areas Covered in the Session : What is Additive Manufacturing / 3D Printing The Design-to-Device Process Methodologies and Materials; Recycling Printing Characteristics and Parameters Unique Device Build Characteristics Standard vs. Patient-Matched Devices Unique Software Considerations Physical and Mechanical Assessment of the Finished Device Acceptance Activities; Test Coupons Validation / Revalidation Submission Requirements Who Should Attend: Research and Development Departments Quality Departments Regulatory Affairs Departments Manufacturing Departments Production Departments Engineering Departments Operations Departments Purchasing Departments Medical products consultants (primarily devices)


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Areas Covered in the Session :

  • Review the current regulatory requirements and guidances (CFR, EU GMPs, ISO, etc.) for environmental monitoring.
  • Discuss issues of sampling methods, selection of sampling sites and the justifications for them.
  • Review the issue of contamination control as an important aspect of EM programs.
  • Discuss the issue of action and alert limits, trending of data and the handling of excursions.
  • What are the most common deficiencies cited by regulatory auditors when auditing environmental monitoring programs?
  • Attendee question and answer period.

Who Should Attend:

  • QA/QC Teams
  • Manufacturing Teams
  • Engineering Teams
  • Validation Teams
  • Regulatory affairs Teams
  • Management Teams
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