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Tuesday, June 18 • 11:00am - 11:30am
#231 CH: Quality in Focus: Diethylene and Ethylene Glycol Challenges

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Component Type: Workshop
Level: Intermediate

Participants will delve into the US FDA's regulatory guidance, exploring the testing protocols for high-risk drug components and explore the essential requirements and recommended practices to ensure product safety and compliance.

Learning Objectives

Recognize key factors contributing to diethylene glycol (DEG) and ethylene glycol (EG) contamination; Examine the US FDA's regulatory guidance, delving into the testing procedures for high-risk drug components contaminated with DEG and EG; Explore requirements and recommended practices for manufacturers, repackagers, preparers, and distributors.

Chair

Chaitanya Koduri

Speakers
CK

Chaitanya Koduri

Director, International Government and Regulatory Engagement, US Pharmacopeia, United States

Tuesday June 18, 2024 11:00am - 11:30am PDT
Content Hub Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  15: Content Hubs, Workshop |   09: Regulatory, Workshop