This pharma training will discuss how to monitor impurities in pharmaceutical products as per ICH Q3 A/B requirements and learn how to measure the thresholds to report for regulatory submission.
 
Learning Objectives:
Upon completion of this session, attendees will understand regulatory requirements in the monitoring of pharmaceutical impurities. Participants will gain practical knowledge about key considerations when reporting impurities for regulatory submission. This session will also discuss observations and infractions that were obtained due to recoding impurities in pharmaceutical labs.
Areas Covered in the Seminar:

• Understand regulatory expectations.
• Discuss warning letters and citations.
• Understand regulatory requirement guidelines surrounding impurities in API and Drug Products.
• Review ICH Q3A for controlling impurities in API and Q3B for impurities in Drug Products.
• Understand different thresholds to report for regulatory submission.

Who Will Benefit:
To get the most out of the course, we highly recommended that you have at least two years of pharmaceutical analysis or drug development experience.

• R&D analysts
• QA and QC Managers
• Regulatory scientists
• Directors