Wednesday June 18, 2014 from 9:00 AM to 4:00 PM EDT
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Distek, Inc.
121 North Center Drive
North Brunswick, NJ 08902

Driving Directions 


Sean Gilmore
Distek, Inc.
+1 732 422 7585


Gregory P. Martin
Complectors Consulting LLC


Full Day
9:00 AM to 4:00 PM





$575.00* (Early Bird Discount)
*If Paid in full by May 19, 2014

Fee includes: Registration, Lunch, Breaks, and Training Certificate.

Course Fee can be paid by Check or Credit Card via PayPal.

Please make check out to Distek, Inc. and mail to:

Distek, Inc.
Attn: Accounts Receivable
121 North Center Drive
North Brunswick, NJ 08902

Reference - COURSE061814


Staybridge Suites
2195 US Highway 1 South
North Brunswick, NJ 08902
Reservations: +1 877 238 8889


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.