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New Elemental Impurities Tests for Pharmaceutical Products According to the New ICH Q3D and USP 232/233 Guidelines

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Deadline: June 27, 2018 | Date: June 27, 2018

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

Updated: 2018-06-10 04:02:10 (GMT+9)

Call For Papers - CFP

Areas Covered in the Webinar:

Elemental Impurities: The case for change

Regulatory status: FDA, ICH Q3D, USP 232/233

Scope of the new guidance on Elemental Impurities - related to ICH Q3D and USP Chapters 232 and 233

What drug products are within the scope of the guidance

Which classes of drug products need to comply with ICH Q3D and which with USP 232/233

How risk assessment influences what testing is required

What documentation related to control of elemental impurities is expected by FDA

Implementation of the Guidelines

Which procedures can be used to demonstrate compliance

Analytical Procedures and how methods should be validated

What you should be doing now?

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