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Laboratory Inspection and Auditing

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Deadline: September 13, 2020 | Date: September 23, 2020

Venue/Country: Philadelphia, PA, U.S.A

Updated: 2020-01-05 11:07:29 (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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