DAY 1 | 8 AM-5 PM
Definitions and Regulatory Requirements
DAY 2 | 8 AM-5 PM
Supplier Selection Continued
Defining Supplier Controls
Communications and Improvements
DAY 3 | 8 AM-12 PM
Integrating Supplier Controls Throughout
the Quality Management Systems
Supply Chain Management
Submissions and Compliance
Upon completing this course participants
will be able to evaluate their organization's compliance with FDA's
requirements for purchasing controls and acceptance activities, and consider
appropriate risk mitigation strategies for supplied products and services.
This course is targeted to professionals
involved in establishing supplier agreements, supplier quality management,
purchasing activities, Quality System compliance, and regulatory submissions
for significantly outsourced products.
A combination of situation analyses, case
study exercises, and both formal and informal discussions are used throughout
the program to provide maximum opportunity for the application of information.
Fee includes electronic versions of the
PowerPoint presentations and case studies, pertinent FDA documents and