Supplier And Contract Manufacturer Management

About The Course:

This 2-day course will cover managing a supplier for the entire lifecycle of the relationship, beginning with identification and qualification of a supplier and continuing through building a relationship, risk management, ongoing assessment (including auditing) and finally planning for an exit. The course will show attendees how to use risk assessment for ranking suppliers and reducing the number of audits that are necessary to effectively manage suppliers. Strategies for determining whether a supplier will be sole source will be included. Exercises will help attendees develop their own supplier scorecard based on the requirements of their company and develop quality agreements that will ensure clear lines of communication. Attendees will take away strategies for the ongoing monitoring of supplier process performance and for managing 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

Areas Covered:

• The benefits and components of a supplier management program
• Regulatory requirements for managing suppliers and contract manufacturers
• Strategic decision making for good supplier management
• How to manage risk and reduce the costs associated with having suppliers
• The steps involved in selecting and onboarding a supplier
• Developing good supplier relationships including managing improvement and nonconforming events
• Writing effective and useful quality agreements
• Reviewing supplier performance and making performance-based decisions
• How to perform a desktop assessment and a supplier audit (and when to use each)
• Managing supplier transitions

AGENDA

Course Director: KELLY THOMAS

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.