FDA considers the supplier as an extension of your operation. You are liable for supplier’s conduct. FDA will deal with your company in case of product failure, especially as related to end user or patient safety concerns.
Areas Covered in the Session:
Learn the pre-selection, selection and assessment process through the use of various tools
Methods, techniques and strategies that work and are proven with supplier relations and qualification
Learn how to apply risk-based approaches and why and how to "rank" suppliers
Supplier Agreements, Quality Agreements and other documentation including Audits/Assessments
Who Will Benefit:
David R. Dills,Global Regulatory Affairs & Compliance Consultant currently provides regulatory affairs and compliance consultative services for early-stage and established Class I/II/III device, IVD, biopharmaceutical, cosmetics and nutraceutical manufacturers on the global landscape, and has an accomplished record with more than 27 years of experience in the areas of Regulatory Affairs, Compliance and Quality Systems.
Compliance4All DBA NetZealous,