Five Steps To Proven Device Purchasing Control Management - Webinar CD/Transcript

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Five Steps To Proven Device Purchasing Control Management: Form 483 Observations Up 17% In The Last Year

Order this CD/Transcript today for a proven 5 step process that not only will assure the FDA finds your purchasing controls sound but also provides you with a system that assures ongoing compliance.

Why You Should Purchase

A recent analysis of 2014 Form 483s issued to devicemakers found that purchasing control violations were up 17% over 2013.  While nearly every other section of the QSR showed decreases, purchasing controls were mentioned in 129 Form 483s — up from 110 in 2013.

In 90 minutes FDAnews and noted device compliance attorney Mike Heyl of Hogan Lovells will present a proven 5 step process to assure the FDA finds your purchasing controls sound — and most importantly —you have a system to assure ongoing compliance.

This presenation will feature tips and tricks such as:

  • Best practices for establishing acceptance criteria to demonstrate sustained suitability of a supplier
  • The 5 things that each approved vendor’s file should contain
  • How to write contracts so that suppliers notify you if any design, product or process change occurs involving your supplied product or component
  • Methods to balance the acceptance activities for low, medium and high risk suppliers

Learning Objectives

In just 90 minutes, you’ll receive a quick overview of how purchasing controls impact the manufacturing process, a brief introduction to how the regulation works, and five proven steps to improve your own purchasing controls program with an eye on FDA expectations.   

In particular you’ll learn:

  • Secrets behind supplier evaluation and picking a supplier that will maintain compliant deliveries
  • How to determine, and defend, the level of control selected for each product
  • Proven strategies to establish and maintain purchasing records acceptable to the FDA
  • The key to a successful and compliant purchasing program — by focusing on data from suppliers
  • Specific tools and tactics to establish and maintain procedures for defensible acceptance activities
  • Medical device manufacturing and executives
  • QA/QC managers and directors
  • Production managers
  • Production supervisors
  • Quality inspection and test managers
  • Purchasing managers
  • Supply chain specialists
  • Process development staff
  • Purchasing staff
  • Compliance officers
  • Training managers
  • Regulatory affairs and compliance professionals

Mike Heyl is a partner at Hogan Lovells,  his practice is primarily in the medical device area.  He focuses on the FDA's Quality System Regulation (QSR) — with special emphasis on adverse event reporting, and field action requirements. His experience includes assisting in the defense of criminal investigations by the U.S. Department of Justice, responding to FDA Warning Letters and Form 483s, conducting internal investigations of alleged violations of federal regulations and corporate codes of business conduct, reviewing and drafting standard operating procedures, assisting clients with import and export issues, conducting regulatory due diligence and assistance with negotiation of corporate mergers and acquisitions and initial public offerings, creating and implementing corrective action plans, and providing general advice on a variety of device-related regulatory issues.