Learning Objectives:
- Understand the benefits of effective supplier management
- Learn about the regulatory requirements for supplier management
- Understand how to develop a strategy for suppliers based on your supply chain
- Be able to analyze the cost of manufacturing vs. purchasing
- Understand how to select a supplier or contract manufacturer
- Understand the basics of building a supplier relationship
- Be able to develop a quality agreement that provides valuable guidance
- Learn how to perform risk assessments on suppliers and how to make decisions based on that assessment
- Learn how to develop a plan for supplier performance monitoring
- Understand how to manage failures and how to work with a supplier for improvement
- Understand the methods of supplier assessment and when to apply each
- Learn techniques for auditing a supplier and for follow-up and closure of the audit
- Learn how to effectively manage supplier exits and the transition to a new supplier
Course Content
Speakers
Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.Utilizing strategic thinking, risk based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.

