***NEW*** Quality Management of Excipient Suppliers

This course is intended for pharmaceutical manufacturers to help them understand and apply criteria for the selection, qualification, and ongoing quality oversight of excipient manufacturers and distributors. The course is helpful to excipient manufacturers and distributors, so they may learn and implement measures to address customer and regulatory requirements.

Registration

Course: 
****NEW*** Quality Management of Excipient Suppliers

Course Description:

  • Regulatory overview
  • Compendial requirements and establishing specifications for non-compendial excipients
  • Procurement from manufacturer vs. distributor
  • Excipient qualification
  • Supplier qualification
  • Excipient supply chain
  • Regulatory expectations
  • Ongoing management
Learning Objectives: 

Upon completion of the course, participants will be able to:

  • Describe general regulatory expectations for excipients in the US and Europe;
  • Describe and develop elements of a qualification program for excipient suppliers;
    • Locate and complete templates for Quality Agreements,
    • Describe expectations for excipient Certificate of Analysis
  • Describe special qualification requirements for procuring excipients through distributors;
    • Compare and explain the differences between different types of distributors and their operations
    • List and discuss the resources available for learning about and assessing Good Distribution Practices
  • Name some methods of determining essential quality/supply chain integrity characteristics of excipient distributors;
  • Describe and develop elements of a supplier quality management program of excipient makers by users; and
  • Describe requirements for performance of ongoing assessments of conformance to GMP

Cancellation Policy

You may cancel your course for a full refund less 5% service fee any time before you access your course.

Must be made in writing and can be mailed or e-mailed to:

IPEC-Americas Workshops
3138 10th street
Arlington, VA 22201
Suite 500
E-mail: ipecamer@ipecamericas.org