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Purchasing Controls: FDA’s Expectations for Compliance

BEST PRACTICES SESSION ROOM  | Wednesday, June 13 | 11:15 am - 12:15 pm
Speakers: John Gagliardi, President, MidWest Process Innovation, LLC; Daniel Walter, Chief, Foreign Enforcement Branch, CDRH, FDA 


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



An ongoing challenge for manufacturers is the establishment and ongoing maintenance of procedures that ensure all purchased or otherwise received products and services conform to specified requirements. This session takes an FDA perspective to address what is required to establish and maintain compliance with 21 CFR, Part 820.50 (Purchasing Controls) and point out how the process architecture of this highly impactful section of the Quality System Regulation is beneficial (in time, dollars and quality)—not only for you, your company and your suppliers, but to all stakeholders along the commercialization chain.

Attendee Takeaways

  1. Learn the advantages of having a simple yet effective supplier agreement in place
  2. Understand FDA’s expectations for your evaluation and monitoring of suppliers, using risk management
  3. Fully grasp the crucial importance of authorizing and documenting changes to established purchasing relationships
  4. Know how to generate and optimally apply the objective evidence required for compliance to 21 CFR, Part 820.50





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.



Walter2 200x200

Daniel Walter is Chief of the Foreign Enforcement Branch in the Division of International Compliance Operations within the Office of Compliance, Center for Devices and Radiological Health (CDRH) for FDA. The branch oversees compliance efforts for medical device manufacturers outside of the U.S. and includes inspection review, recall classification and administration of allegation of regulatory misconduct, as well as assists the office, Center and Agency with cross-cutting initiatives for all device types. Mr. Walter began his career at FDA as a compliance officer and was promoted to lead the Vascular and Circulatory Support Branch in the Office of Compliance at CDRH. He is a member of FDA’s Device Curriculum Committee and collaborates with various divisions to develop cross-cutting mechanisms to enhance patient outcomes through information sharing and “benefit/risk” based evaluation processes. Prior to working with FDA, Mr. Walter was a Validation Engineer for several companies, eventually serving as Lead Quality Auditor and Director of Quality at DST Controls. His experience includes facility, utility, equipment and process validations for automated and non-automated systems.


Related reading from BONEZONE®: 
Purchasing Controls: Draft the Best Supplier Quality Agreement

Risk Management: The Science of Minimizing Uncertainties