FDA`s Expectations from Supplier Management for GMP: Quality Agreements and More 2019

Topics

• Responsibilities of manufactures and suppliers
• Regulatory requirements for supplier qualification
• What are the FDA’s expectations in regards to quality agreements?
• Best practices for supplier selection, qualification and management
• Best practices for a good quality agreement
• What is meant by the title owner, contractor, adulterated drug, and the term manufacturing within the guidance?
• Documentation requirements and audit trails
• Supplier audits

Who should Attend

• Regulatory Affairs/Regulatory Compliance Directors, Managers, and Specialists
• Quality Assurance/Quality Control Directors, Managers, and Specialists
• Engineering/Development Directors, Managers, and Specialists
• Purchasing/Materials Management Directors, Managers, and Specialists
• Document Control Managers and Specialists