Control of Impurities in Pharmaceutical Products: Impurities, Degradants, Residual Solvents, Elemental Impurities

This course is designed to provide an overview of impurities which must be controlled in pharmaceutical products, detailed review of the guidance documents related to each of the categories of impurities and strategies to address each, including reporting of test results.

Course Overview

1. Assessment of Class Needs.
2. Overview of Impurities in Pharmaceutical Products Requiring Control.
3. General Impurities.
4. Drug Related Impurities.
5. Strategies for compliance while minimizing resources.
6. Questions and Discussions.

Learning Objectives

• Learn about the new requirements for Elemental Impurities and current plans for implementation.
• Discover strategies to minimize resources necessary to control Residual Solvents.
• Learn differences between drug-related impurities and degradants, and techniques to assist in predicting degradants.
• Get the latest information on potential DNA reactive/mutagenic/genotoxic impurities and expectations for their control.

Cancellation Policy

Cancellation or rescheduling must be made within 10 business days prior to the start of the course to avoid a 50% billing fee to the attendee.  A one-day cancellation or no-attendance will result in full billing.

Distek, Inc. reserves the right to cancel any course 10 business days prior to the course where the minimum enrollment is not met.  The purchase of non-refundable airline tickets is not recommended due to possible course cancellations.

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