USP International Workshop on Single Use Systems 2018

The Use of Single Use Systems in the Manufacturing of Pharmaceuticals and Biopharmaceuticals: Current Thinking and Things to Consider

Suzhou, China

Register Agenda

Overview

Plastic manufacturing systems have been increasingly used in manufacturing processes， particularly biological manufacturing processes. Despite their multitude of advantages, these plastic assemblies also draw concerns about chemical compounds that may migrate to finished products and impact product quality or safety. Evaluation of such manufacturing systems and their potential impact remains a challenge for suppliers and end users. Thus, the Packaging and Distribution Expert Committee is developing a practical and science-based approach for the qualification of plastic manufacturing systems. The intention of the workshop will be to engage stakeholders, both domestic and international from standard-setting organizations, regulatory agencies, Single Use Systems (SUS) suppliers and end-users.

Sessions

• Session 1: Regulation Landscape and USP Consideration for SUS
• Session 2: Strategy and Techniques for Extractable and Leachable Study of SUS
• Session 3: Best Practice and Challenges for SUS Validation

Who Should Participate

Personnel from the following functional areas of Pharmaceutical, Device and Biotechnology companies will benefit from this workshop: 

• Process Development
• Analytical Development
• Research and Development
• Regulatory Compliance
• Manufacturing/Operation Packaging
• Quality Assurance
• Quality Control
• Quality Audits
• Validation Engineer
• Packaging Engineer
• Academic Research involving SUS quality and analytical technologies

Pricing Information

Registration fee includes the full 1.5-day program, meeting materials, coffee breaks, and lunches. Registration fees for this workshop have been set as follows:

A 50% group discount will be provided for 3 or more people from the same organization