Quality Systems for Contract Clinical Supply Operations: Using Risk Analysis to Meet Global Requirements

Time

Tue, Jun 25 11:45AM
T 15

Title

Quality Systems for Contract Clinical Supply Operations: Using Risk Analysis to Meet Global Requirements

Abstract Summary

Using the experience as a CMO focused on sterile products, data were compiled from customer batches ranging from small innovator firms to established, multi-national companies, each with unique perspective and approach to meeting regulatory requirements for clinical supplies at each phase . Product types span a wide range, from conventional small molecules to vaccines and conjugates. Principles of risk analysis were used to identify areas where rigid infrastructure was required to maintain an appropriate state of control in manufacturing operations. Best practices identified from regulatory requirements of markets served were implemented throughout the organization.

Poster Presenter

Sarah Wartman
Lyophilization Technology, Inc.
United States

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