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Design Controls: Building Objective Evidence and Process Architecture
to Meet FDA and ISO Compliance

BEST PRACTICES SESSION ROOM  | Thursday, June 14 | 10:00 am - 11:30 am
Speaker: John Gagliardi, President, MidWest Process Innovation, LLC



    While all attendees will benefit from this session, the check marks indicate the skill level and roles that this session targets.
    Beginner  |   Intermediate  |  Advanced

  √ Manufacturing
Product Management
 √ Quality Control
√ Regulatory/Clinical Affairs
√ Research/Development/Design
 Supply Chain Management



This session will provide detailed examples to demonstrate what objective evidence is important to generate and use during design control compliance but, more importantly, to develop and issue a beneficial design history file meeting the requirements in 21 CFR, Part 820.30 and ISO 13485:2016. Besides the importance of design controls for compliance, Mr. Gagliardi will demonstrate how this section of the QS regulation and the ISO standard can be facilitated as a leading edge business tool.

Attendee Takeaways

  1. Generating the proper objective evidence from the beginning of design controls
  2. Talking through your compliance using examples and process architecture
  3. Development of a Design Matrix
  4. Constructing a Design History File throughout the design controls process





Gagliardi 200x200John Gagliardi has had success over more than four decades 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 as President of MidWest Process Innovation, LLC.


Related reading from BONEZONE®: 
8 Design Control Issues Found During FDA Inspections

Synergetic Dissimilarity: Design Validation/Verification and Process Validation | Design Controls: Design Transfer, Changes and the Design History File

Don't Treat Your FDA Inspection Like an ISO Audit