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Session 1: FDA Focus on Design Controls Session 2: CAPA: Using Risk-Based
Decision-Making Toward Closure

FDA Focus on Design Controls

Design controls are not an easy subject to address during and after the design of medical devices and manufacturing processes. Design controls should drive the device design process, not be an afterthought. This session focuses on treating design as a separate entity within the quality management system, user needs vs. design inputs, continuation of design controls after the transfer process, design review and more.

Session Takeaways:

  • How to treat design as a separate entity within the Quality Management System (QMS)
  • How user needs are not design inputs
  • The use of the Design History File as the basis for the Device Master Record
  • The use of design validation using production units or their equivalents follows successful design verification
 Who Should Attend:
  • Product Management
  • Quality Control
  • Research/Development/Design

Prepare for this Session:


CAPA: Using Risk-Based Decision-Making Toward Closure

Implementing a risk‐based CAPA process within a QMS is a necessity in the improvement of controls aligned with product and process non-conformances, adverse events, audit findings, complaints, etc. Making decisions concerning scope and extent about these “defectives” is a modern and cost-saving approach to improvement and compliance.  Every non-conformity does not force you to open a corrective action. While almost every problematic issue needs at least a correction, the biggest payback is to use corrective actions on systemically-driven problems that are repetitive and recurring.

Applying the methods of determining risk to the device’s complete life cycle will give your company a complete look at all of the device’s risks—including those relative to processes. Manufacturers should be able to justify that they have reduced the risks as far as possible as part of their risk management plan and ongoing corrective and preventive actions.

Session Takeaways:

  • How to identify the root cause of the non-conformance or adverse event
  • How to use risk management to identify a device’s risk
Who Should Attend:
  • Materials/Commodity Management
  • Purchasing
  • Quality Control
  • Supply Chain Management
  • Manufacturing
  • Executive Management

Prepare for this Session:


John Gagliardi, President, MidWest Process Innovation
JohnGagliardi webJohn Gagliardi is President of MidWest Process Innovation LLC. He has had success over the past 45 years in the medical device and pharmaceutical industries because of his practical approach to process orientation and business. He has been actively involved in research and development, quality assurance, training, operations, process architecture, FDA inspections and regulatory affairs. Mr. Gagliardi specializes in building systems in a compliant and business-ready manner.