Five Steps to Proven Device Purchasing Control Management

Date	Feb 27, 2015
Time	11:00 AM EDT
Cost	$287.00
Online

Join us on February 27 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 Attend

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, February 27, 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 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 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

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

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