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