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    HTTP://WWW.COMPLIANCEONLINE.COM/IMPURITIES-IN-PHAR 2015 - Monitoring Impurities in Pharmaceutical Products - ICH Q3 requirements

    View: 322

    Website http://bit.ly/18seT7c | Want to Edit it Edit Freely

    Category FDA GXP Compliance - Pharmaceuticals

    Deadline: March 04, 2015 | Date: March 04, 2015

    Venue/Country: Palo Alto, U.S.A

    Updated: 2015-02-27 13:31:12 (GMT+9)

    Call For Papers - CFP

    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.

    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

    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.

    Use coupon code 232082 and get 10% off on registration.


    Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
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