2021 - FDA’s Expectations from Supplier Management for GMP: Quality Agreements and More

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