Effective management of suppliers and contract manufacturers is an integral component of a quality management system. Suppliers are an integral part of the supply chain and, therefore, the process of production and delivery should by understood and supplier relationships developed and improved. Supplier failures can increase the cost of poor quality through excess inventory, downtime, additional testing, and customer satisfaction. On the other hand, a significant strategic advantage can be gained by excellent supplier management. One of the seven quality principles of ISO 9001 is to build relationships with suppliers because it is a critical component of sustained success.
Pharmaceutical and medical device manufacturers have a mandated responsibility for ensuring the suppliers meet regulatory requirements and produce good quality product. FDA regulations CFR 210 and 211 require pharmaceutical companies to assure the quality of the product they put into interstate commerce regardless of where it or any of its components were manufactured. The Q10 Pharmaceutical Quality System Guidance provides additional details on the agency’s expectations for supplier management. For Medical Device Manufacturers, 21 CFR 820.50 places the burden on the purchasing company to establish purchasing controls. European regulations similarly require effective supplier quality management.
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
Who will benefit:
In the pharmaceutical, medical device, cosmetic, or personal care industries: quality assurance managers, quality control laboratory supervisors, quality engineers, procurement professionals, drug development scientists, medical device development scientists, supply chain managers
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