This comprehensive supplier management course is designed to enhance your skills in effectively managing supplier relationships throughout their lifecycle. From supplier identification and qualification to building strong relationships, risk management, continuous assessment, and exit planning, this course covers it all. Learn how to leverage risk assessment techniques to rank suppliers and minimize the need for extensive audits. Gain valuable insights into determining whether a supplier is suitable for sole sourcing. Engage in practical exercises to create your own customized supplier scorecard tailored to your company's requirements and develop quality agreements that promote clear communication. Walk away equipped with strategies for ongoing supplier process performance monitoring and efficient management of nonconforming incidents and changes.
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
DAY 1 (10 AM to 3 PM)10:00 AM - 11:30 AM | Session 111:30 AM - 12:45 PM | Session 212:45 PM - 02:00 PM | Session 3DAY 2 (10 AM to 3 PM)10:00 AM - 11:30 AM | Session 411:30 AM - 12:45 PM | Session 512:45 PM - 02:00 PM | Session 6
Objectives:
Understanding Regulatory Requirements and Standards for Supplier and Contract Manufacturer (CM) Management:
European Union (EU) directives and guidelines
The Cost of Poor Quality from Suppliers and CMs:
Strategic Management of Suppliers:
Risk Management - A Lifecycle Approach:
Supplier qualification:
Supplier qualification:
Making your Supplier Quality Agreement a Great Resource:
Monitoring Your Supplier’s Performance to Reduce Risks and Costs:
Partnering with a Supplier or CM for Improvement:
Supplier Assessments:
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.