Monitoring Impurities in Pharmaceutical Products to meet ICH Q3 A/B Requirements by ComplianceOnline


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									    Monitoring Impurities in Pharmaceutical Products to meet ICH Q3 A/B Requirements

                                October 27, Wednesday 10:00 AM PDT | 01:00 PM EDT

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 con-
ducted 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.

Date: October 27, Wednesday 2010
Time: 10:00 AM PDT | 01:00 PM EDT
Duration: 60 Min
Instructor: Kim Huynh-Ba
Location: Your office or conference room (no need to travel!)
                                                                                                              Kim Huynh-Ba

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

   Instructor Profile:

                 Kim Huynh-Ba, is the founder and Technical Director of Pharmalytik ( She has 23
                 years of experience in various analytical areas of pharmaceutical development and a primary focus in stabil-
                 ity sciences. Prior to Pharmalytik, she held positions in drug development at Astra Zeneca (formerly ICI
                 Americas), DuPont Merck, DuPont Pharmaceuticals, Bristol Myers Squibb and Wyeth Vaccines. She has
                 been advising pharmaceutical companies including companies operating under FDA Consent Decree since
                 2001. She is a well known speaker at many national and international conferences. Kim is an Adjunct Profes-
                 sor at Illinois Institute of Technology and Temple University, School of Pharmacy. She serves on the Execu-
                 tive Committee of Eastern Analytical Symposium (EAS) and a member of the USP General Chapters Expert
                 Committee (2010-2015).
  Registration Information:

      * Register Online. Use your American Express, Visa or MasterCard.
      * For more than one attendee get 20% off on the price of additional attendee.
     * Get your group to attend the webinar at a discounted price call +1- 650-620-3937.
     * Call +1 - 650-620-3937 or Fax your PO: 650-963-2556.
      * Mail your check to: ComplianceOnline (MetricStream, Inc), 2600 E. Bayshore Road, Palo Alto, CA 94303.

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