Wednesday May 14, 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 7, 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 - COURSE051414


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


Effective Investigation of Out of Specification, Out of Trend or Atypical Results

This course is designed to provide sound training on how to recognize and address atypical or out of specification results, using approaches which have been recommended by regulatory authorities. It also informs participants how to perform investigations to assure both compliance and good business decisions.

Course Overview

  1. Assessment of Attendees Backgrounds and Interests.
  2. The FDA Guidance for Industry on Investigating OOS Test Results.
  3. Conducting the Investigation.
  4. Evaluating the Outcomes: Has the Root Cause been identified?
  5. Documenting the Investigation.
  6. Case Studies.
  7. Interactive Workshop: Participants’ Examples.
  8. CAPA.
  9. Utilizing Outcomes for Continuous Improvement.
  10. Questions and Discussions.

Learning Objectives

  • Recognize the drivers to address investigations effectively.
  • How to complete investigations faster and with less stress.
  • Tools for finding the Root Cause: brainstorming, risk assessment, hypothesis testing.
  • The critical link between Root Cause Analysis and CAPA.
  • Making sure CAPA has really addressed the issue.

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.