FDAnews Announces — Five Steps to Proven Device Purchasing Control Management: Form 483 Observations Up 17% in the Last Year Webinar, Feb. 27, 2015

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A recent analysis of 2014 Form 483s issued to devicemakers found that purchasing control violations were up 17% over 2013. Join FDAnews on Feb. 27 for a proven 5 step process that not only will assure the FDA finds devicemakers purchasing controls sound but also provides them with a system that assures ongoing compliance.

Join FDAnews on Feb. 27 for a proven 5 step process that not only will assure the FDA finds devicemakers purchasing controls sound but also provides them with a system that assures ongoing compliance.

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.

On Friday, Feb. 27, FDAnews and noted device compliance attorney Mike Heyl of Hogan Lovells will present a proven 5 step process to assure the FDA finds the purchasing controls sound and most importantly a system to assure ongoing compliance.

This webinar 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 manufacturers if any design, product or process change occurs involving a supplied product or component
  • Methods to balance the acceptance activities for low, medium and high risk suppliers

In just 90 minutes, attendees will 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 a purchasing controls program with an eye on FDA expectations.

In particular attendees will 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

Meet the Presenter:
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.

Who Will Benefit:

  • 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

Conference Details:
Five Steps to Proven Device Purchasing Control Management:
Form 483 Observations Up 17% in the Last Year
**FDAnews Webinar**
Feb. 27, 2015 — 11:00 a.m. – 12:30 p.m. EST
http://www.fdanews.com/DevicePurchasingControlManagement

Tuition:
$487 per site -- includes webinar registration and audio cds and transcripts

Easy Ways to Register:
Online: http://www.fdanews.com/DevicePurchasingControlManagement
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

Five Steps to Proven Device Purchasing Control Management:
Form 483 Observations Up 17% in the Last Year
**FDAnews Webinar**
Feb. 27, 2015 — 11:00 a.m. – 12:30 p.m. EST
http://www.fdanews.com/DevicePurchasingControlManagement

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Michelle Butler
FDANEWS
+1 (703) 538-7665
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