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    Laboratory Inspection and Auditing

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    Deadline: September 13, 2021 | Date: September 23, 2021

    Venue/Country: online event, U.S.A

    Updated: 2021-07-17 12:36:12 (GMT+9)

    Call For Papers - CFP

    Quality auditing of pharmaceutical quality control laboratories is an important activity for those performing due diligence or monitoring the performance of a sub-contractor. Besides covering GMP regulations affecting pharmaceutical quality control, this one-day course is designed to provide the non-specialist with the necessary knowledge to understand the quality significance and risk associated with different analytical operations.

    By the end of the course, attendees will be able to:

    Identify non-conformance to cGMP regulations in analytical operations

    Understand the key steps in the analytical process

    Recognize commonly-used analytical techniques and instruments

    Appreciate the significance of pharmacopoeias in analytical operations

    Understand the requirements for controlling reference standards, reagents and important consumables

    Appreciate the importance of GMP controls over analytical method suitability (validation, verification and transfer)

    Classify analytical instruments according to quality risk and understand the qualification requirements for each class

    Understand current expectations for data integrity controls, including electronic data systems

    Identify non-conformances in the control of stability studies

    Appreciate the regulatory requirements for reference and retention samples

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