In an age where manufacturing efficiency has become critically important for FDA-regulated manufacturers, outsourcing has become a global phenomenon.
Third party suppliers and vendors can go a long way in lowering costs and filling in-house gaps. But failing to properly manage third party partners can pose huge risks to product safety and compliance with FDA's Regulations.
On top of this, FDA has repeatedly promised greater scrutiny of global supply chains—stepping up import inspections and penalties for noncompliance.
Plan on marketing products in the EU? New changes implemented by Notified Bodies now require greater scrutiny of your suppliers.
Whether you're looking for new qualified third parties or simply need to strengthen your current quality management system, we hosted a free webinar covering everything you need to know to maintain quality and prevent compliance problems now and in the future.
Watch our free recorded webinar free presentation and learn:
- The regulatory requirements for supplier management
- How to qualify and select suppliers, vendors and other contractors
- How to write an effective supplier quality agreement
- How to adopt a risk-based approach to supplier quality management
- How supplier auditing can be used to ensure quality on a routine basis
About the Presenter
Instructor Larry Stevens, RAC, has held almost every field position within FDA during his 21-year career with FDA, and has over 18 years of experience in the Medical Device industry rising from an RA Manager to Vice President of RA/QA/Clinical for major class III device manufacturers.