Purchasing Controls for Medical Device Companies
Duration: 90 Minutes
This webinar can help you understand your responsibilities in terms of Purchasing Controls, enabling you to provide safe and effective products to your customers. Learn how to prevent quality and compliance problems by having a strong system for Purchasing Controls!
Purchasing Controls have received significant scrutiny from the FDA in recent years due to an increase in adverse events and recalls. Purchasing Controls continues to be a leading source of 483 and Warning Letter citations. Finished Device Manufacturers have had to deal with significant quality issues including recalls because of purchased materials and components.
Objectives of the Presentation
- Understand FDA expectations for Purchasing Controls
- Understand lessons learned from recalls and other major quality issues
- Steps to developing effective purchasing controls
- How the FDA will determine cracks in your process
- How to manage your suppliers
- Learn what documents the FDA will want to see
Why Should you Attend
- Types of suppliers
- Supplier evaluation
- Determining the type and extent of control
- Maintaining and disseminating purchasing data
- Incoming material and acceptance activities
Medical Device manufacturers routinely outsource some or all of their design, manufacturing, or other activities. However, suppliers of components and sub-assemblies are not independently required to comply with the Quality System Regulation (QSR). Therefore, it is imperative that finished goods manufacturers have processes in place to ensure the quality of any purchased products from suppliers.
Additionally, the QSR imposes Purchasing Control Requirements on finished goods manufacturer. Finished goods manufacturers must have a strong system in place to identify, evaluate, and monitor suppliers. They must be able to prioritize and determine the extent of controls required for each suppler.
Who can Benefit
- Individuals new to Medical Device Companies
- Supplier Quality Engineers
- Compliance Personnel
- Managers and Individuals in Purchasing / Supplier Management