Risk in Pharmaceutical Quality: Role of the Documentary and Reference Standard. Case Studies.

Tuesday, October 22, 2024

9:30 AM – 10:30 AM MT

Location:360 Stage #2, Exhibit Hall

Sponsored By

Manufacturing and Analytical Characterization

Partner Presentation-Manufacturing & Bioprocessing

Partner Presentation Speaker(s)

Naiffer Romero, MSc, MPH (he/him/his)

Principal Scientist
US Pharmacopeia
Rockville, Maryland

Handouts

Description: In the complex landscape of pharmaceutical development and compliance, ensuring the highest quality of products is paramount and accurate measurements are at the heart of pharmaceutical quality assessment. This presentation will cover the pivotal role that Reference Standards play in mitigating risks and will shed some light on practical cases in which inaccurate measurements can influence the reliability of analytical results and can lead to erroneous conclusions about product quality and safety.

Learning Objectives:

Learn the risks to pharmaceutical quality and the impact of the use of non-fit for use RS and Analytical Procedures
Gain insights into how inaccurate measurements can lead to erroneous conclusions about product quality and safety
Understand the critical stages of Reference Standards development process: What is suitability for use and how to minimize Risks to Quality