Supplier Evaluation and Internal Auditing for FDA and ISO 13485 Compliance: Pack of Three Courses

This pack of three training courses provides 3.5 hours of training on review of QSR and ISO requirements for supplier evaluation and assessment, and cost efficient options to many of the common practices and also provide the principles and practices needed to effectively develop, implement, and perform internal quality management system audits that comply with the requirements of the FDA QSR Regulation and ISO 13485 and EU MDR 745/2017.

All Modules:

• Module 1: Supplier Management: Challenges and Opportunities
• Module 2: Supplier Management with the new Medical Device Regulation EU MDR 745/2017
• Module 3: Streamlining your QMS and Audit System for Remote Audits
• Part 1 : Supplier Management: Challenges and Opportunities

Areas Covered in the Webinar:

• Supplier Selection
• Review of FDA and ISO requirements
• Types of suppliers that must be qualified
• Defining critical suppliers
• Classification of suppliers
• Outsourced processes
• The Quality Agreement
• Recommended Practices

Supplier Assessment

• Review of FDA and ISO requirements
• Recommended Practices
• How to avoid “Death by Supplier Audit”
• Documentation requirements