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  • Monitoring Impurities in Pharmaceutical Products - ICH Q3

  • Hosted By:
  • ComplianceOnline
  • Start:
  • Thursday - Jan 16, 2014 10:00 AM
  • End Time:
  • Thursday - Jan 16, 2014 11:00 AM
  • Location:
  • Online
  • This training will discuss regulatory requirements for monitoring of pharmaceutical impurities. It will explain how to monitor impurities in pharmaceutical products as per ICH Q3 A/B requirements and to measure the thresholds to report for regulatory submission.

    Why Should You Attend:
    Monitoring impurities is considered a critical activity of analytical development in order to ensure the quality of the pharmaceutical products. Current ICH Guidelines indicate that the measurement of impurities should always be conducted for active pharmaceutical ingredient (API) and its drug products. This session will discuss the requirements of ICH Q3A/B for monitoring impurities in API and drug products, practical considerations when examine impurities, how they are reported in regulatory documentation, and key factors to consider when setting impurity specifications.

    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
    -Regulators and Researchers who are responsible for providing analytical data pertaining to pharmaceutical products

    Instructor Profile:
    Kim Huynh-Ba, has almost 25 years of experience in analytical development, project management, strategic drug development and stability sciences. She is the Executive Director of Pharmalytik, where she provides consulting and training services to pharmaceutical companies including companies operating under FDA’s Consent Decree on harmonization and optimization of analytical best practices. Prior to this position, she was the Director of Pharmacopeial Education Department of U.S. Pharmacopeia (USP), where she was responsible for their education programs worldwide. Kim has held several technical and quality positions at Astra Zeneca (formerly ICI Americas), DuPont Merck, DuPont Pharmaceuticals, Bristol Myers Squibb and Wyeth Vaccines. Kim is also a short course instructor on cGMP compliance and quality topics for several global organizations such as American Chemical Society (ACS), American Association of Pharmaceutical Scientists (AAPS), Pittsburgh Conference, and many other international training groups. She is an Adjunct Professor at Temple University-School of Pharmacy, Widener University and Illinois Institute of Technology teaching pharmaceutical analyses and analytical chemistry graduate courses.
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